Clinical Scientist Resume Samples

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C Feeney

Carmel

Feeney

478 Wintheiser Underpass

San Francisco

+1 (555) 630 7056

478 Wintheiser Underpass

San Francisco

Phone

p +1 (555) 630 7056

Experience Experience

Dallas, TX

Clinical Scientist

Dallas, TX

Doyle, Hagenes and Greenfelder

Dallas, TX

Clinical Scientist

Providing leadership and management within CD to provide scientific and clinical development support for products within assigned therapy area
Update and develop operational processes to improve efficiency, quality and consistency of clinical trial management across Early Development, including
Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs
Establish an extensive network of contacts in the scientific community
Support in developing clinical trial design, protocol development, and execution (Phase II-IIIb)
Contribute to the evaluation of clinical sites and external service providers perform-ing TM studies in healthy volunteers
Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,

San Francisco, CA

Clinical Scientist Lead

San Francisco, CA

Tremblay-Collins

San Francisco, CA

Clinical Scientist Lead

Assists the GDTL/GCDL in providing scientific clinical development advice to the project teams for the development of Phase I-IV clinical programs
Assist the Clinical Development Physician and/or theGCDL in the review of trial data and development and review of clinical study documents, reports etc,
Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs
Assists in drug safety surveillance for Development projects
Responsible for providing scientific support for the company’s clinical research and product development initiatives under the direction of GCDL/GDTL
Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
Participates in drug safety surveillance for Development projects

present

Philadelphia, PA

Senior Clinical Scientist

Philadelphia, PA

Steuber, Funk and Turner

present

Philadelphia, PA

Senior Clinical Scientist

present

Self-motivated, willingness to take the initiative to identify opportunities for improvement and take actions to improve
Reports significant progress and final findings of projects to management and product development staff in the company
Reviews clinical data with some assistance and contributes to the development of clinical presentations and integration of analyses into clinical documents
Performs other duties as assigned related to clinical programs
Engage in team discussions and provide support for assigned projects
Assist with planning and setting up of meetings with external experts – Ad board, consulting and steering committees
Review study related documents such as data management plan, eCRF completion guidelines, data validation manuals, database UAT

Education Education

Bachelor’s Degree in Physics

Clark Atlanta University

Bachelor’s Degree in Physics

Skills Skills

Ability to use scientific and clinical knowledge to conceptualize study designs
Excellent Oral and Written Communication, with ability to influence senior decision making in relation to specialist discipline
Ability to act as both Dangerous Goods Safety Advisor and Radioactive Waste Advisor for PETIC
Strong in reading English literature and writing SCI papers, good communicate skills in English
Good team member and interpersonal skills. The ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion
Ability to manage multiple projects in a fast paced setting while maintaining attention to details and precision in testing techniques
Ability and desire to develop good working relationship internally and externally
Able to work independently, to implement new ideas where appropriate, and be able to fully research, troubleshoot and report on technical issues
Ability to conduct research and setup research studies
Ability to work independently with minimal guidance as well as collaboratively within a team setting

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Temporary Clinical Scientist Resume Examples & Samples

Function as a clinical investigator which includes conducting biophysical testing on human subjects
Learned use of clinical testing instrumentation to collect data from human subjects, ensuring collection of consistent, measurable data
Maintain detailed data logs for clinical studies and provide data on a timely basis
Perform data entry of raw data into EXCEL spreadsheets
Follow clinical testing protocols to ensure accurate testing parameters
Instruct panelists on proper use of test products and devices
Maintain a professional clinical atmosphere, demonstrate an excellent level of customer service, and ensure diversity sensitivity all for panelists on a daily basis
Maintain awareness of panelist issues, i.e. product adverse reactions, questionable compliance, etc, and escalate issues to Supervisor to ensure proper testing results
Demonstrate an excellent level of service and provide results on a timely basis
Respond to requests from management, as necessary
Learn and follow all SOP’s under GCP guidelines
Bachelor’s degree in chemistry, biology or other Science
Strong technical skills
Strong Organization and Detail skills
Must be able to handle multiple projects simultaneously in a fast-paced setting while maintaining attention to detail and precision in testing techniques
Excellent written, verbal, and customer service communication skills
Computer skills including Microsoft Word, Excel
Medi-spa/esthetician experience a plus

Clinical Scientist Resume Examples & Samples

BS in a scientific field (biology, pharmacology, biochemistry, chemistry, etc) with some knowledge of pharmacokinetic terminology
Pharmaceutical industry experience and having worked in a highly matrixed organization is desirable
Strong communication and multi-tasking skills are required
Highly self-motivated and likes to contribute toward problem solving

Clinical Scientist Resume Examples & Samples

Bachelor degree required /Masters degree preferred
At least 5 years of clinical research experience or higher degree. Regulatory affairs experience a plus
Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred
Develops and manages clinical protocols and amendments, informed consent forms, training material, case report forms, diary cards, clinical study reports and other clinical documents, and contributes to the development of investigator's brochures. Ensures compliance with regulatory guidelines in the development of documentation
Oversees study conduct and communicates study-related information to investigators and study staff. Oversees and tracks recruitment and retention of study subjects
Manages study timelines. Reports on study progress and provides options for handling problems that develop. Provides progress updates and summaries to management. Develop tools and processes that increase efficiencies of the project
Prepares regulatory documents for FDA and other regulatory submissions. Supports management with implementation of departmental strategies and policies

Clinical Scientist Resume Examples & Samples

Provides clinical scientist input into all regulatory questions, runs ad hoc searches
Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc,
Support GDTL/GCDL to provide scientific leadership in execution of clinical trials
Assist in the review, analysis and reporting of clinical trial data
Assist with ongoing monitoring of safety data and regular medical review of clinical trial data
Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution (Director)
Collaborates with Global Development Team Lead, and Global Clinical Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and consistent
Assist the GDTL/GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
Participates in drug safety surveillance for Development projects
Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred
Significant late-stage development research

MR Clinical Scientist Resume Examples & Samples

Masters degree in Life Sciences, Chemistry, Physics, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or related field
Strong relevant work experience
Strong English language oral and written communication skills
PhD Degree in Physics, Chemistry Biomedical Engineering or related field
Demonstrated record of innovation in development
Experience preparing research proposals and technical documents
Experience on acquisition, reconstruction and medical image analysis, particularly in Magnetic Resonance
Experience in a clinical environment (e.g. radiology or cardiology department)
Self-starter, energizing, results oriented, and able to multi-task
Demonstrated ability to work in a collaborative, matrixed, team and customer focused environment
Ability to travel up to 40%

Clinical Scientist Resume Examples & Samples

Providing leadership and management within CD to provide scientific and clinical development support for products within assigned therapy area
Support development and execution of medical & clinical strategy for assigned Shire product(s)
Preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
Act on behalf of Medical Monitor (GCDL) leading the interpretation of trial data and development and review of clinical study documents, reports etc,
Participation/contribution to cross-functional team meetings; Provide support or act as senior company representative interacting with external scientific leaders and/or Regulatory authorities
This position may be combined with the GCDL position when the program is limited in its scope and complexity
Collaborates with Global Development Team Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches
Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings
Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
May supervises a variable number of CD professional and administrative staff;; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems
Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs
Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
Significant experience (12+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization

Clinical Scientist Lead Resume Examples & Samples

Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams
Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings
Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs
Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
Participates in drug safety surveillance for Development projects
Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
Significant experience (10+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
Demonstrated ability to collaborate in a matrixed environment
Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities,

Clinical Scientist Resume Examples & Samples

Provides scientific/clinical oversight for respective area of projects and collaborates with operational project managers and directors assigned to area programs. Consults with appropriate internal and external customers regarding the respective area’s clinical development, regulatory issues, and points of interest
Assists team, including CRAs and Project Managers, in understanding the therapeutic area and specific condition(s) being studied
Develops general and project-specific training
Develops and maintains a professional and clinically oriented relationship with the functional area team members, including biostatisticians, data managers, and medical monitors
Prepares Product Development Plans and collaborates with respective internal departments regarding other reports, applications, and regulatory submissions to include
Engaging outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input in order to prepare the outline and type of content required for the respective Product Development Plans
Interacting and collaborating with the Medical Writing department in the preparation of Product Development Plans, as well as sections/items of Investigational New Drug Application (INDs), New Drug Applications (NDAs), and other marketing/licensing applications to be provided to FDA and/or non-US regulatory authorities as required
Interacting and collaborating with the Regulatory Affairs department regarding adverse event reporting and adverse event reports for NDAs and other regulatory submissions as required
Participates in the development and review of clinical trial protocols, applicable study plans, statistical analysis plans, and clinical study reports. Conducts reviews of study documents and plans (e.g. Case Report Forms, Laboratory Forms, Clinical Monitoring Plan, etc.) to ensure the study is operationalized to achieve appropriate outcomes
Contributes in the selection of and works with any vendors or Company staff involved in the use of microbiologic, virologic or pharmacokinetic specific assays and tests. Reviews laboratory specifications, manuals, data transfer agreements, methods, and plans. Supports the project team with invoice and data review
Assists in final assessment of data for specialized vendors requiring 100% Quality Control
Leads the planning and set-up of study related materials and systems related to microbiology sample management, the microbiology data flow, and all aspects of the clinical case review
Conducts the review of randomized subjects in phase 2-3 studies in conjunction with the medical monitors and other assigned team members. Leads team evaluability reviews conducted during a study to determine outcomes and/or populations to which a subject will be assigned. Responsible for developing plans to document the procedures and determinations of such reviews
Facilitates communications between the Customer and the Company, as well as participates on customer proposals, Requests for Information, presentations, proposal defenses, etc. May be responsible for leading the proposal team where the respective product development activities are involved
Communicates with CRA’s, Investigational Site Clinical Staff, and microbiology staff to support site selection, set-up, or study execution as needed
Serves as the respective area’s Subject Matter Expert to ensure an appropriate level of understanding such that project teams consistently operate in compliance with sound research principles. Provides scientific oversight and program/product development training to Company staff and project teams
Trains junior Infectious Disease Project Scientists in the role
May assist the Vice President in developing policies and procedures
May contribute to the Company by attending industry meetings, participating at booth exhibitions, speaking, etc., and by publishing scientific or industry-related articles in industry journals
Researches and makes recommendations on current regulatory requirements, as they pertain to microbiology, and industry practices related to the respective area’s product development in the US, Canada, Europe and other key markets

Clinical Scientist Resume Examples & Samples

Conduct background research on indications and studies to establish references and scientific base
Utilize knowledge of clinical trial design to develop specific study concepts and protocols
Participate in protocol review discussions concerning scientific and procedural aspects of study design
Develop clinical documents (study protocol, investigator brochures, consent forms, study reports, etc) in accordance with FDA regulations
Provide input to the design of CRFs
Identify and resolve issues related to study design and execution
Assist with the ongoing review of summary data including safety, primary efficacy variables and lab data
Assists in the preparation and review of key regulatory documents, submissions, and annual reports. Present clinical performance data to FDA reviewers and other regulatory officials
Plan, draft and revise scientific manuscripts for publication
Write and present abstracts describing study data for clinical conferences
Minimum of BS or equivalent, MS, PharmD or PhD in field relevant to clinical research preferred
Hospital training preferred
Minimum 3 years with PharmD or Ph.D, 5 years with M.S. and 8 years with BS
Must demonstrate excellent writing and organizational management abilities
Expert ability in Microsoft Word, Power Point and Excel as well as scientific graphing applications
Familiar with clinical operations and FDA and HIPAA rules, regulations and guidelines
Knowledge of good document management practices
Ability to use scientific and clinical knowledge to conceptualize study designs
Ability to anticipate and resolve problems
Ability to lead cross functional efforts and teams
Proficiency in data interpretation
Clinical project management skills
Excellent skills in oral and written communications
Ability to work independently with minimal guidance as well as collaboratively within a team setting

Senior Clinical Scientist / Medical Writer Resume Examples & Samples

Bachelor's Degree or equivalent in related field and 7 years + related scientific experience required OR
Master's Degree or equivalent Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in related field 5 years + related scientific experience required
Expertise in cardiovascular disease is preferred
Experience with Class III devices preferred
Excellent writing skills, command of drafting, editing and reviewing
Knowledge of biomedical databases and search strategies (PubMed, Embase)
Knowledge of clinical research and basic statistical/clinical concepts
Strong verbal, written and interpersonal communication skills
Strong computer skills (MS Word, MS Powerpoint, Endnote bibliographic management)
Overnight travel for professional meetings and/or working sessions may be required. Travel is estimated to be 10%

Clinical Scientist Resume Examples & Samples

Contributes to the design and implementation of clinical development programs incorporating understanding of relevant nonclinical, clinical and published literature
Prepares materials and presents at advisory boards and other relevant external forums
Interacts with academic thought leaders to optimize clinical trial strategies and support management of the conduct of the clinical trials
Conducts analysis of clinical data including safety monitoring in collaboration with Medical Director(s) and Drug Safety
May deliver key presentations, both internally and externally, to provide updates on strategies, plans and other activities
In collaboration with Medical/Scientific Affairs, writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
Coordinates submissions to scientific meetings and/or other appropriate venues
Assists with design, development and writing of clinical protocols and other clinical trial documents
Develops scientific training materials for internal and external training to support clinical operations and development activities
Writes clinical science sections of Regulatory meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
Works with EVP of Research & Development to drive ongoing data generation and identify new programs for relevant therapeutic areas

Clinical Scientist Resume Examples & Samples

Collaborate with internal teams, CROs and external vendors to prepare, review and finalize clinical protocol documents
Contribute to aspects and stages of the protocol development and execution from study design planning through final reporting of result
Provide scientific input and review of protocol data, medical monitoring reports, study integrity/conduct and protocol oversight
Support preparation of abstracts, manuscripts, presentations, and materials for meetings as it related to the protocol(s) and program
Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e. IND submissions, IND Annual Updates, DSUR, Investigator Brochures, and briefing books) and aid in the development of responses to regulatory authorities when questions arise for the protocol
Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies
Bachelor's degree in life sciences or related field of study
Minimum of 2 years of experience in clinical trial/drug development
Knowledge of pharmacokinetic applications related to drug disposition
Strong medical writing and presentation skills
Understanding of biostatistics and data management
Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents
Ability to work in high paced working environment
Demonstrated team-building skills and the ability to work successfully in a matrix team environment
Analytical, negotiation, meeting management, cross-functional team and leadership skills
Experience with EDC systems, experience with RAVE and J-Review preferred
Skills in conflict management, time management and organizational
Travel requirement approximately 5-10% based on protocol development stage and program needs

Clinical Scientist, Oncology Resume Examples & Samples

Assists the Program Lead and study team with the scientific conduct of clinical studies
May have specific task assignments for a single study or across multiple studies, e.g, adjudication support, medical monitoring, data management deliverables, preparation of meeting materials, safety and medical monitoring
Demonstrated leadership skills with ability to work in cross-functional teams
Demonstrated oral and written communication and computer/database management skills
Must have excellent oral (including presentation) and written communication, project management, and computer/ database management skills
Must have awareness of pharmaceutical industry needs beyond clinical development

Senior Clinical Scientist, Oncology Resume Examples & Samples

Accountable for the clinical/scientific execution of the clinical protocol
Accountable for the scientific aspects of the implementation and conduct of a clinical trial (e.g., investigator meeting presentations, safety and medical monitoring)
May serve as the CSSM scientific representative on the clinical trial team (CTT)
May collaborate with the Medical Writer on clinical/scientific and regulatory documents and Study manager on study deliverables
Excellent oral (including presentation) and written communication, computer/ database management and project management skills
Experience in Oncology Clinical Research

Senior Clinical Scientist Resume Examples & Samples

Work with cross-functional team with oversight by the Medical Lead to conduct clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities
Prepare literature reviews as needed
Life sciences degree with at least 4-6 years of clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy
Advance degree in life sciences (e.g.; PharmD/PhD, Masters, Nursing, etc.) with 2+ yrs of clinical research experience in the pharmaceutical industry or healthcare setting
Experience in all stages of drug development

Clinical Scientist Lead Resume Examples & Samples

Responsible for providing scientific support for the company’s clinical research and product development initiatives under the direction of GCDL/GDTL
Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles on assigned studies and projects
Assist the Clinical Development Physician and/or theGCDL in the review of trial data and development and review of clinical study documents, reports etc,
Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables
Serve as a resource to address medical questions or clarify issues arising during conduct of the study
Assist with ongoing monitoring of safety data and regular review of clinical trial data
Supports the GDTL or GCDL when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings
Assists the GDTL/GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
Assists the GDTL/GCDL in providing scientific clinical development advice to the project teams for the development of Phase I-IV clinical programs
Assists in drug safety surveillance for Development projects
Significant experience (> 5 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
Experience in designing and conducting Phase II-III clinical trials; and/or

Director Clinical Scientist Resume Examples & Samples

Significant experience (5+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO, an academic research program or similar organization is required
Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities
Experience in designing and conducting Phase I-III clinical trials; and/or
Expertise in hematology preferred
Demonstrated in-depth understanding of drug development and pharmaceutical marketing within Therapeutic area
Working knowledge of regulations relating to drug development and promotional activities
Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers
Management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work preferred
Ability to create and maintain and organizational structure that serves the needs of the business
Ability to capitalize on business opportunities by developing well thought out strategies and initiatives
Availability to travel approximately 25% of time
Availability to participate in early or late meetings/teleconferences

Associate Director, Clinical Scientist Resume Examples & Samples

Masters or PhD (preferred) degree is required. Scientific/healthcare field preferred but not required
Experience (3+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO, an academic research program or similar organization is required
Demonstrated ability to collaborate in a matrix environment
Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences
Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results
Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization
Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry
Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results. Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts. Requires high degree of problem solving ability; understanding of objectives and processes across multiple organizational functions

Senior Clinical Scientist Resume Examples & Samples

Ensure scientific support for operational realization within the CSO for study(ies) or registries he/she is allocated to, under the functional supervision of the CSD and/or Medical Operations management, by securing the operationalization of the medical validation/review plan (reports and trackers)
Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of decreasing the complexity
For all new protocols, is in charge of calculating the protocol complexity index, before and after protocol review, and after any protocol amendment
Is involved in some of the medical reviews of study data under the CSD supervision, support the CSD for the medical review of data with the manual reconciliation of the case by case review of safety events reported to GPE or safety events of special interest, listings
Help for the preparation, organization and minutes of study Committees, follow the contracts with business support
Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (extended synopsis, protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form…). Participates to the CTT and monitoring team training on medical information
Provide or prepare medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct
Support CSD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project
Support CSD in organizing Steering committees, Data Monitoring Committees, Adjudication Committee meetings
Develop good quality management practices, including guidelines, as regard to medical review/validation activities
Support to regulatory documents filing and archiving
In collaboration with study team, including UMO, is in charge of designing, providing cost elements related to the study design
Promote and develop use of electronic tools (A/J review, e-PP) in the context of medical review /validation
Develop study specific training material for training to Medical advisors and sites
Propose and develop in coordination with CSD and CTOM/DM study specific medical data points checks based on protocol efficacy criteria. With CTOM track and follow-up on missing data related to these criteria
With CSD, define precisely the critical data, and implement/develop related sections of the study risk management plan
Coordinate medical validation/review activity with CME and GSO from GPE, notably to anticipate and prevent last minute queries or backlog, and smoothen the process
Scientific expertise or interest and ability to learn in the domain of assigned study/project
High level of autonomy and motivation
Quality focused and well organized
Strong communication skills (verbal and written)
Ability to handle multiple tasks and to prioritize
Ability to synthesize the information, good presentation skills
Excellent decision-making and problem-solving capabilities
Capability to challenge decision and status quo
Ability to work autonomously and to efficiently & effectively provide status reports
Ability to anticipate and timely escalate issues and to define appropriate action plans
Team and results oriented
Teaching skills, ability to assist and train others
Strong English skills (verbal and written if English is the second language )

Clinical Scientist Resume Examples & Samples

As Clinical Monitor Local (CML) effectively leads local trial team and Canadian vendors to ensure that assigned Canadian trials are completed on time, within budget, and with high quality
As Research Associate (RA), assigned on a trial, provides support to the CML to ensure that assigned Canadian trials are completed on time, within budget, and with high quality
Ensure adherence to governmental regulations, international guidelines, and company Standard Operating Procedures in the conduct of clinical trials
Degree, often with higher degree/qualification (e.g. PhD, MSc) in Life Sciences, Business or Others
Practical clinical research management experience is an asset. Candidates with extensive clinical research experience, demonstrated competencies, and Clinical Research certification (e.g. ACRP, SOCRA or equivalent) may be considered in the absence of above educational requirement
1-3 years Leading Projects
Ability to work independently in a multi-tasking, time-line and team-oriented environment

Assistant Director Clinical Scientist Resume Examples & Samples

Contribute to (assist the clinical lead in) the clinical development plans in collaboration with the project MD including evaluation of translational medicine and biomarker strategy, discussions with clinical investigators and advisors and contingency planning
Comfortable with the review of medical clinical data. Prior responsibility for creating and driving a clinical analysis plan
Experience developing strong networks internally and externally beyond initial field of expertise
Malignant hematology experience is preferred

Clinical Scientist Resume Examples & Samples

Collaborate with project and functional teams in Translational Development on compound strategy and tactics and development of Translational Development Product Development Plans
Key clinical lead in cross-functional sub-team meetings in collaboration with the Medical Monitor
Author, develop, and amend clinical study protocols, consent forms, case report forms and ancillary documents in collaboration with the Medical Monitor and study teams
Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock
Work with the Medical Monitor and translational scientists in data preparation and review for Safety Review Committee meetings, Candidate Development Committee (CDC) meetings, Quarterly Review meetings and various internal and external meetings
Work with the Medical Monitor and translational scientists in preparation of abstracts, posters, oral presentations and manuscripts on Early Development trials and compounds
Guide the Study Manager, CRAs, and others, in prioritizing the day-to-day management of clinical studies
Work with biostatistics and the project team to perform research and analytics and provide recommendations to support quality medical and scientific decisions regarding translational research, consultancy, and internal planning
Attend professional meetings and congresses, as relevant, to support and represent early development compounds
Actively engage/interact with key stakeholders, including
Internal: medical monitor, clinical operations, translational scientists, translational development leadership, project leadership, data management and biostatistics, regulatory affairs, medical writing, QC/CQA, clinical pharmacology, preclinical toxicology, CMC
External: clinical investigators, study coordinators, advisory board participants
Update and develop operational processes to improve efficiency, quality and consistency of clinical trial management across Early Development, including
Generation of Phase 1 and 2 protocol templates
Development of more efficient processes for protocol development and amendments
Improved processes to optimize efficiency of subject screening and enrollment
More efficient methods for real time data review, compilation and analysis
Bachelor's Degree required
Advanced degree(s) in relevant field: RN/PharmD/PhD with experience in oncology disease indications preferred
Extensive academic/industry experience including 2-5 or more years relevant experience in clinical/translational research working on IND and other regulatory submissions,
Previous experience in Clinical or Translational Development and proficiency in oncology disease indications required

Clinical Scientist Resume Examples & Samples

Function as a clinical sub-investigator which includes follow clinical testing protocols to ensure accurate testing parameters, conducting biophysical testing and collecting consistent data on human subjects in accordance with GCP and company's SOPs
Perform data entry and analysis of raw data using EXCEL
Prepare protocols, study report forms, informed consents and reports
Instruct panelists on proper use of test products to assure compliance
Stay current on cosmetic field trends and technological developments of data collection instrumentation

Clinical Scientist Resume Examples & Samples

Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors including but not limited to protocols, charters, safety monitoring plans, IND reports, process documents and disease and/or treatment registries
As an active member of the Protocol Execution Team, oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and representatives from Biometrics and Clinical Operations
Participate in tracking/analysis of any potential safety events within an individual clinical trial and across trials for assigned program(s)
Serve as a Clinical Science representative on cross-functional teams as assigned, e.g., Protocol Execution Team, Safety Sub-Team, Biomarker Sub-Team, cross-functional initiatives
In conjunction with the Medical Director, serve as primary point of contact for clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions
In conjunction with the Medical Director and other cross-functional representatives (e.g., Biometrics, Clinical Operations, CRO), coordinates the preparation, analysis and review of data outputs for reporting documents where appropriate (e.g. clinical study reports, analysis plans, etc.)
Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan
Identify and implement processes to share clinical information across teams/molecules/indications
In conjunction with the Medical Director, create and or review presentations for internal and external meetings (e.g., Investigator meetings, pre-study site selection visits (PSSV) and site initiation visits (SIVs), Study Coordinator and CRA training, Advisory Boards, and internal and external medical/scientific meetings). Develop and review clinical data outputs with biostatisticians to support these activities
Maintain awareness of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory) that may impact the investigational agent Clinical Development Plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review
As assigned, participate in development of the long-range strategic plans for the assigned program(s)
As assigned, participate in Clinical Science assessment of in-licensing opportunities
As assigned, mentor and/or train new Clinical Scientists

Clinical Scientist / Study Operational Lead Resume Examples & Samples

Clinical Trial Leader for Phase I/II studies including multi-country / multi-center trials
Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and project team members
Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings
Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised
Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan, and other study essential documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
In collaboration with the Medical Expert and CTT, manage the ongoing medical/ sci-entific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are trans-ferred/available in a timely manner
Contribute to the evaluation of clinical sites and external service providers performing TM studies in healthy volunteers
Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions
Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear del-egation /assignment of duties are documented
Act as a mentor to support the training and on-boarding of new CS&I associates
Provide advice to other departments and line functions and to cross-functional working groups as required. Function as a Subject Matter Expert as assigned
Identify areas for process or technology improvements
Responsible for following best practices and standards for trial management within TM; expected to share lessons learned
Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies. Assist or perform training for CTA and Clinical Scientists
Approximately 3 plus years experience in clinical trials / drug development
Good knowledge of Good Clinical Practice
Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities
Clear written and verbal expression of ideas, an active/proactive communicator
Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing with a wide range of people, building strong positive relationships
Used to working independently and in a team environment, being flexible and adapting in a changing environment

Associate Director, Clinical Scientist Resume Examples & Samples

Support Medical Lead with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in communicating a clear overview of trial results
Excellent oral and written communication skills and solid computer/analytical skills
Ability to think creatively and innovatively
Global clinical research experience
Oncology experience a plus (only for oncology position postings)

Clinical Scientist Resume Examples & Samples

Under the direction of the Medical Director (or designee), coordinate and conduct clinical evaluations for technical documentation ensuring compliance with applicable regulations (e.g., MEDDEV 2.7.1, ISO 14155, etc.) and company procedures
Define the scope and clinical evaluation plan by coordinating inputs from cross-functional subject matter experts (e.g., R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, etc.)
Appraise data sets to evaluate scientific validity, relevance, and weighting in accordance with MEDDEV 2.7.1
Analyze available clinical data and technical information, and derive conclusions related to compliance with Essential Requirements, device performance, and technical equivalence
Prepare well-written and compliant Clinical Evaluation Reports (CERs)
Obtain required approvals and ensure that Clinical Evaluations remain current according to the required update schedule
BS in clinical/medical discipline (e.g., nursing, PA, NP, etc.) with commensurate training and experience
Master’s Degree, MD, DO, or PhD in a clinical/medical discipline strongly preferred
Prior experience performing scientific literature reviews, and the ability to critically evaluate clinical data to draw conclusions related to device safety, performance, and technical equivalence
Prior experience preparing high quality technical documents and performing clinical evaluations and systematic literature reviews is preferred

Clinical Scientist, Sleep Development Resume Examples & Samples

Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision making
Develop phase II-IV clinical protocols as part of a clinical development team
Prepare clinical portions of all relevant regulatory filings (INDs, meeting requests, NDAs, etc.)
Help identify clinical investigators and coordinate their activities for the conduct of clinical trials and advisory board meetings
Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials
Prepare clinical data and clinical program presentations
Generate and supervise the drafting of clinical study reports
Assess the accuracy of clinical data in clinical documents
Represent the company at scientific and industry conferences, as needed
Outstanding written and oral communication skills
Proven ability to work independently and as part of a multidisciplinary team
Collaborative and flexible in personal interactions
Passionate about improving patient care
2+ years of corporate, government, or academic pharmaceutical development experience preferred
2+ years of experience in scientific research is required, with CNS or Sleep Medicine expertise preferred
Travel required (up to 5-20% of time)
PhD, MD, DO, PharmD, or other advanced scientific or clinical degrees considered

Clinical Scientist MR Resume Examples & Samples

Support the customer in how to set up research projects between Philips and academia
Be an ambassador for the research sites in Sweden towards Philips
Provide specific support to method development and testing
Support collaboration between institutes with mutual interests
Keep oneself scientifically updated

Clinical Scientist Resume Examples & Samples

Provide follow-up support by disseminating technical & scientific information on specific applications, helping the customer with his scientific work on our products
Provides technical expertise through sales presentations and assists during product demonstrations
Assists the sales staff in assessing potential application of company products

Clinical Scientist Resume Examples & Samples

Bachelor's degree in Science (Chemistry, Biology or related field)
3-5 years’ experience
Proficient in Microsoft Word, Excel, Access, PowerPoint, and Outlook
Organization skills
Multi-tasking skills
Strong technical and analytical skills
Ability to manage multiple projects in a fast paced setting while maintaining attention to details and precision in testing techniques

Clinical Scientist Resume Examples & Samples

Collaborates with Global Development Team Lead, and Global Clinical Team Lead, to ensure that all development and product support activities for the assigned projects are coordinated and consistent; provides scientific advice within Shire R&D and other functions leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches
Assists and/or leads the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy
Significant late-stage development research preferred; early phase research experience will contribute to overall assessment

Clinical Scientist Resume Examples & Samples

Be the expert/MR specialist on an assigned Technical or Clinical application area
Establish an extensive network of contacts in the scientific community
Be actively involved in the clinical road mapping process
Keep up to date with innovations in MR technology and medical applications in area of clinical expertise via scientific literature, symposia and international conferences
Develop an in-depth knowledge of Philips’ MR Technology
Be able to run the Philips’ MR scanners (incl. workstations) independently, and do patient/volunteer scanning
Guide clinical research, pre-product development and clinical validation of MR related products and applications
Guide marketing and sales activities including site visits of strategic customers; establish frameworks for trouble shooting image quality (IQ) issues
Be able to Advise colleagues in Product Marketing on new technical and clinical developments, assist in writing commercial and technical commercial documents
Be able to Advise colleagues in R&D on new technical and clinical developments
Write white papers, Works-in-Progress brochures, leaflets, slides and video material etc. on new clinical applications for the use of Sales and Marketing
Manage all clinical activities related to designated research sites and initiate, guide and manage the MR research projects
Co-ordinate with the local (US) clinical science organization and the clinical science organization in the MR headquarters (Best, The Netherlands) on all clinical and research issues including image quality, clinical applications, new research tools, clinical science keys and other new (proto-type) MR techniques. These activities may encompass
MR Physics and MR System Programming
Development and advanced application in a clinical setting on MR systems
Cardiac expertise a plus
Ability to conduct research and setup research studies
Professional communication, teaching and presentation skills essential
Social skills (interaction with customers, other departments, sales organization)
Languages: fluent English in writing and speaking
Travel within North America
Occasional international travel (clinical science meetings, development team interaction)
Ph.D. degree in physics, chemistry, biomedical engineering or other relevant technical background or

Senior Clinical Scientist Resume Examples & Samples

Understanding of scientific process as well as medical and statistical concepts
Understanding of all aspects of clinical development from program planning to regulatory submission
Excellent oral (including presentation) and written communication, computer/database management skills
Ability to influence and collaborate internally as well as externally with partners and study-related vendors

Clinical Scientist Resume Examples & Samples

Applies clinical and scientific expertise to all duties, including but not limited to mentoring, staff and site training, CST touch point design, data reviews, site interactions, and proposal development
Develops and maintains a professional, collaborative, and clinically oriented relationship with the investigators and their staff
May perform any or all of the following duties depending on the CST services provided in the assigned project
Trains the CST staff in the therapeutic area under study and applicable instruments
Works with CST project team and leadership to design CST touch point reviews and process planning
Works with CST project team and Business Unit leadership to develop clinical surveillance plan documents, budgets, timelines, and other supportive documents
Presents CST materials and plans at kick-off meetings, quick-start camps, investigator meetings and other internal or sponsor meetings as necessary
With guidance from a more senior Clinical Scientist and CST Director, supports the Business Development Department and Business Unit by providing information and/or slide presentations covering CST capabilities, patient populations, and activities. Presents on behalf of CST at Customer capabilities and bid defense meetings
Lends clinical expertise and guidance to project teams within Business Unit as needed
May perform Project Director or Project Manager tasks as needed
May have line management responsibilities for one or more staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods

Senior Clinical Scientist Resume Examples & Samples

Facilitates and collaborates with key internal/external stakeholders (trial team, subsidiary country teams, vendors, committees, etc) in support of clinical trial objectives
Accountable for managing any trial specific partners and/or vendors
Responsible for collaborating wth the Medical Writer on protocol development, clinical study reports, regulatory documents and Study Manager on study deliverables
Responsible for regulatory agency update reports, responses to regulatory agencies, and other clinical and regulatory documents
Contributes to the authoring of CTD/WMA subsections
Supports Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, etc
Ability to contribute and collaborate with a team including proactive issue identification and resolution. Must be able to make independent, timely, data-driven and appropriate decisions
Must have excellent, demonstrated oral (including presentation) and written communication, and computer/database management skills
Demonstrated project management skills with proven ability to lead cross-functional team and individuals
Minimum 3 years’ experience in Infectious Diseases areas of pharmaceutical industry preferable. Medical writing experience a plus

Clinical Scientist Resume Examples & Samples

Test and evaluation of prototypes (hardware and software)
Initiation and Coordination of clinical multi-center trials
Active involvement in research projects initiated by the local Principal Investigator of the host institution and/or Philips
Technical support during site visits of strategic account customers. Facilitation of users groups
IQ trouble shooting
Initiate new training programs and review quality of clinical training programs
Publish periodically research results in scientific journals and present results at scientific conferences, user or clinical science meetings. Innovate in the field of MR and process ideas to patent applications
MR Interventional Suit / Operating Room experience a plus

Senior / Clinical Scientist Resume Examples & Samples

The position holder contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan. This includes authorship/ review of clinical documents (protocols, IBs, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program
Contributes to the clinical oversight and medical guidance in collaboration with the (AD), Director, (GECDL), and (GCTP) during the conduct of the study
Reviews clinical data with some assistance and contributes to the development of clinical presentations and integration of analyses into clinical documents
Liaisons with internal stakeholders (Research, Preclinical Toxicology, Global Clinical Operations, Data Management, Statistics, Global Clinical Safety and Pharmacovigilance, Commercial Development, and Regulatory Affairs) and external investigators, vendors and other support functions
Builds experience analyzing and interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents through assisting with such activities
Assists with the planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, AdBoards etc)
Manages the processes required to support external study review committees; e.g data monitoring committees, steering committees
In collaboration with Clinical Pharmacology, and where skilled to do so exist, undertake quantitative clinical pharmacology activities in support of pharmacometric deliverables for R&D projects
Contributes to multidisciplinary task forces to support continuous improvement (i.e. quality circles, SOP harmonization)
Involvement in cross-functional, multicultural and international clinical trial teams preferable. Experience in medical/regulatory writing preferable

Clinical Scientist Resume Examples & Samples

Support in developing clinical trial design, protocol development, and execution (Phase II-IIIb)
May interact with the FDA, corporate partners and cross-functionally across Genentech
Contribute to authorship and review process for scientific publications and presentations

Senior Clinical Scientist, MR Resume Examples & Samples

Keep up to date with innovations in Magnetic Resonance and medical applications, via scientific literature, symposia and local/international conferences
Develop in-depth knowledge on Philips Magnetic Resonance
Provide clinical requirements and support to product development

Senior Clinical Scientist Resume Examples & Samples

Performs extensive analysis of data using statistical methods
Identifies scientific problems and applies scientific principles to the solution of a broad range of complex problems
Performs analysis of small and large data sets
Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized 4-year or more academic course of study
Experience with successful publications
Demonstrated ability to analyze and evaluate technologically complex devices
Proven interpersonal, facilitation, presentation, quantitative, analytical, organizational, multi-task, and follow-up skills
Ability to meet deadlines as well as the ability to converse effectively with all levels of employees, management and customers
Demonstrated personal computer skills including relevant applications such as R, SAS, Matlab, Python

Clinical Scientist Oncology Resume Examples & Samples

Prepare the clinical science component of the project specific manual
Review SDV (source document verification) plans based on protocol specifications
Attend and provide science support for investigator and consultant meetings and monitors workshops
Provide training and science input to operation colleagues and study site staff, and serve as trouble-shooter and expert on clinical and medical issues and aspects of assigned studies
Write study reports and assist in preparing materials for use in presentations and advisory committee meetings, and provide response to regulatory agency questions
Support the marketing team on clinical issues; co-ordinate, prepare, and review study results for publications, abstracts, poster presentations and scientific meetings

Clinical Scientist Resume Examples & Samples

Bachelor’s/Master’s degree in Scienc, Nursing or related to field with 6+ years of experience in the pharmaceutical industry or PharmD/PhD with 2+ years
Ability to provide input and direction to clinical research with appropriate supervision
Strong desire to collaborate in a cross-functional setting
Clinical of early phase clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable
Ability to interact externally and internally to support global scientific and business strategy
Must possess excellent oral and written English communication skills

Regional Clinical Scientist Resume Examples & Samples

Keep abreast of clinical, regulatory, market, design and technical developments in the relevant areas through clinical workflow analysis, Medical Advisory Boards, frequent clinical visits, literature research and conference participation
Initiate 'clinical investigation studies' and 'post-market clinical studies' to gather scientific evidence for publications using state of the art protocols and study designs, in close collaboration with marketing on the required proof points
Make knowledge available for operational use within Philips to support (regional) marketing efforts and increase market awareness and acceptance of new technology solutions, by demonstrating the added value to clinical outcome and/or workflow efficiency, through transfers of clinical science results to Marketing, Application and Development

Senior Clinical Scientist Medical Imaging Informatics Resume Examples & Samples

Ph.D. or equivalent in Clinical Informatics, Biomedical Engineering, Computer Science, EE or related fields with 3+ years of relevant experience, ideally with a focus on medical imaging informatics
3+ years research experience in the design, development, and evaluation of clinical decision support applications for radiology and/or oncology
Demonstrated experience in working with physicians and designing clinical studies to measure the impact of clinical decision support tools
3+ years of experience leading research project teams
3+ years of experience in applying image/text processing, pattern recognition and/or machine learning techniques for clinical questions
Strong hands-on experience on clinical decision support, including algorithm development and implementation
Working knowledge of CT, MRI, US and other imaging modalities and DICOM
Thorough understanding of at least one workflow among radiology, cardiology and oncology
Excellent programming skills in Matlab, C, C#, R or equivalents
Working knowledge of database technologies (e.g. SQL)
Working knowledge of statistical methods to evaluate the performance of clinical studies
First author publications in relevant leading peer-reviewed journals
Taking ownership, driving for results, and team-player
Flexible and quick learner
Working knowledge of software prototyping environment (Java or C# / WPF / .Net)
Experience with relevant data visualization tools such as Tableau
Understanding of the business and economic considerations associated with healthcare innovation

Early Clinical Scientist Resume Examples & Samples

Knowledge of clinical research development process from program planning to regulatory submission
Knowledge of GCP, ICH guidelines and regulatory requirements
Able to quickly develop a working scientific knowledge of different therapeutic areas
Scientific, medical and/or safety writing and reporting (at least one is required)
Ability to partner effectively with internal and external (CRO) teams to achieve results
Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills

Senior Clinical Scientist Resume Examples & Samples

Strong knowledge of clinical research procedures, GCP and SOPs and understanding of drug development process
Independent data review
Involvement in cross-functional, multicultural and international clinical trial teams preferable
Experience in medical/regulatory writing preferable

Clinical Scientist Resume Examples & Samples

The position will involve late stage clinical development with a novel agent for Alzheimer’s Disease currently in Phase III trials, as well as future compounds for other neuroinflammatory indications
The Clinical Scientist will act as a clinical representative on a number of cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies. This will require close and frequent interactions with a number of other functions including operations, biometrics, safety, regulatory affairs, medical affairs, and a variety of business and commercial functions
The position will involve close and frequent, but remote interactions with other members of the team which are largely based in Basel, Switzerland. Occasional travel to Basel may be required for face to face interactions with the team
Additional responsibilities may involve participation in clinical aspects of the biomarker program, interactions with research, and assessment of in-licensing opportunities

Clinical Scientist Resume Examples & Samples

Generate Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 and the soon-to-be-released Medical Device Regulation (MDR)
Provide Health Hazard Evaluations (HHEs) and clinical assessments to support Quality Assurance and Complaint Handling activities
The incumbent will play a vital role in CE Marking of current and future Image Guided Therapy (IGT) products
5 most important responsibilities
Advanced degree (e.g., MS, MD, PhD, PharmD) in a scientific discipline
Minimum of 3 years medical device industry experience in a Clinical, Scientific, Regulatory, and/or Medical Affairs role
Track record of successful Clinical Evidence Report (CER) generation
Direct experience with adverse event (AE) / serious adverse event (SAE) evaluation for both pre-market and post-market medical devices
Excellent written and verbal English communication skills

Clinical Scientist, Venetoclax Resume Examples & Samples

Support in developing clinical trial design, protocol development and execution (Phase II-IIIb), and filing activities
Clinical support on implementation teams, providing subject matter expertise, clinical science support and functional representation
Build relationships and scientific outreach within the oncology specialty community

Clinical Scientist Resume Examples & Samples

Function as a clinical scientist which includes designing and executing clinical testing protocols to ensure accurate testing parameters, conducting biophysical testing and collecting consistent data on human subjects in accordance with GCP and company's SOPs
Perform data entry and analysis of raw data using EXCEL or appropriate statistical tools
Responsible for the development appropriate proof of concept studies to understand efficacy, mechanism of action, and validation of potential claims

Clinical Scientist Resume Examples & Samples

Master’s degree in neurosciences or psychology/sociology
Minimum of 3 years of clinical research experience
Ability to work in a highly matrixed and geographically diverse business environment
This position requires strong verbal and written communication skills, and interpersonal skills
Experience in clinical research within the medical device or pharmaceutical industries
Knowledge of neuromodulation technologies and chronic pain research

Clinical Scientist Resume Examples & Samples

Support the technical and clinical research program in the field of Magnetic Resonance in Radiation Oncology
Execution of research projects in collaboration with academic sites
Engage with and motivate external and internal stakeholders
Represent Philips as a valued member of the research consortium
Attend and present at conferences, symposia and educational events
Analyze and report research results for Invention Disclosures and Scientific Publication
Contribute to the MR Therapy strategy and roadmap by clinical and technical expertise
Establish and maintain an extensive network of contacts in the scientific community

Clinical Scientist Resume Examples & Samples

Postgraduate degree at MSc level in Medical Physics or in a related subject area
Corporate Membership of the Institute of Medical Physics and Engineering or meets the criteria for membership
A member of the Health and Care Professions Council register of Clinical Scientists or eligibility for the register
Substantial experience working at a Clinical Scientist within Positron Emission Tomography or Nuclear Medicine
Able to demonstrate expert knowledge and understanding of Positron Emission Tomography or Nuclear Medicine, including relevant legislation, national standards, professional and other guidelines
Experience of using specialist software packages (e.g. PMod, Matlab, HERMES)
Excellent Oral and Written Communication, with ability to influence senior decision making in relation to specialist discipline
Evidence of ability to make research and solve expansive problems using initiative and creativity; identify and propose both practical and innovative solution
PhD in Medical Physics or related subject
Track record in Research and Development
Knowledge of other medical imaging techniques
Experience of working in a Higher Education environment

Senior Associate, Clinical Scientist Resume Examples & Samples

Prepare scientific reports/presentations related to clinical trials using available software and templates and; review/contribute to clinical protocols, by utilizing expertise, to assist in interpretation of data
Coordinate advisory meeting agendas, activities and slide decks and consulting agreements
Comply with procedures set forth in relevant IQS documents and Study protocols and other directives issued by the management regarding clinical studies
Lead the study development by applying most current electronic document conventions/processes most consistently/accurately to ensure scientific integrity of all processes. Delete
Responsible for receiving and completing tasks and assignments from function, Therapeutic Area MD or Scientific Staff within timeline with minimal supervision and; maximizing individual, function/therapeutic area and team productivity
Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management
Apply experience to analyze clinical study data, including statistical data using available software to assist with ongoing blinded/un-blinded PK, safety and efficacy reviews and ensure the scientific integrity of all processes
Perform literature/competitive intelligence searches to recognize/resolve scientific and technical problems by applying the most current electronic document conventions and processes consistently and accurately
Provide/present key clinical study information to function/therapeutic area and management
May lead teams within therapeutic area and supervise exempt and/or non-exempt direct reports and mentor function/-therapeutic area personnel

MR Clinical Scientist Resume Examples & Samples

Be the expert/MR specialist on the assigned clinical application area
Keep up to date with innovations in MR technology and medical applications in area of clinical expertise, via scientific literature, symposia and international conferences
Be actively involved in research projects, both in-house and in hospitals
Collaborates with medical doctors and physicists of Clinical Science sites in evaluating new clinical applications of MR, develop, document and maintain clinical roadmaps
Advise colleagues in R&D, Product Marketing and Applications on new technical and clinical developments, assist in writing commercial and technical documents
Interacts with global Philips MR Clinical Scientists on site, provide first-line helpdesk support for research related questions for other Philips colleagues
Regularly visit Clinical Science research sites: discuss innovations with medical doctors, report on new developments, collect new marketing materials

Clinical Scientist Resume Examples & Samples

PhD/MD degree in radiology, clinical, medical physics, bioengineering, medical imaging, computer science or related field
Familiar with medical imaging prefered
Strong presentation skills (public speaking and lecture experience desired)

Executive Director, Clinical Scientist Resume Examples & Samples

In conjunction with other relevant functional areas, develop the strategic development plan for development candidates
Oversee the writing of protocols, and the analyses of data for this compound
Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for these compounds and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems independently
Ensure compliance with AMAG SOPs, ICH, GCP and other national and international regulatory requirements
Assist in oversight/coordination and strategy of publication plan for development studies
Assist CMO in scientific meetings and presentations
Minimum of 5-7 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s)
Strong track record in drug development/medical affairs preferably in a variety of therapeutic areas. Ability to work collaboratively in a challenging team matrix environment
Ability to work independently to resolve challenges and conflicts
Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
Have a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes
Experience in filing sNDAs/NDAs

Director Clinical Scientist Resume Examples & Samples

Help author and review protocol and study design, amendments, IB, clinical sections of IND/IMPD and CTAs fillings, annual reports, clinical study reports, and risk-management plans, and regulatory documents (INDs, NDAs) under the guide of the project physician
Closely liaise with operational group to ensure study design feasibility
Seek collaboration/input from key line functions
Assist in preparation of regulatory responses
Identify core competencies of potential study sites for all phases of oncology trials from a scientific/strategic perspective (distinct from the evaluation given by clinical operations)
Assist in the conduct of study site initiation visits (preparation, personnel training, etc.) and study start-up + close-up meetings, global investigator meetings (preparation of the scientific and medical communication)
Present and discuss project and study strategy with key internal stakeholders, KOLs, advisory boards
Assist study physician with review of the safety and efficacy data (“DDR”, PV, coding when appropriate)
Provide operational oversight for
A Ph.D. in a related field or Pharm.D required
Minimum of 5 years of post-graduate experience, of which at least 3 years include direct involvement with clinical research
Malignant hematology experience
Demonstrated ability to work a global product with key functional groups in a matrix environment
Familiar with phases of clinical research on a global basis- preferably pivotal and Phase III trials
Excellent communication skills – oral and written

Clinical Scientist Resume Examples & Samples

Support clinical oncology study teams with analysis of trends, safety and efficacy, quality check clinical data periodically and query issues
Review study related documents such as data management plan, eCRF completion guidelines, data validation manuals, database UAT
Draft and review clinical sections in regulatory and clinical documents such as study protocols, DSUR, investigator’s brochure, PIP application, conference abstracts, slides for presentation
Assist with planning and setting up of meetings with external experts – Ad board, consulting and steering committees
Engage in team discussions and provide support for assigned projects

Clinical Scientist Resume Examples & Samples

Flexible, focussed, enthusiastic ,self-driven, highly motivated,
Ensures authored clinical documents meet SOP/Document Standard requirements
With Clinical Operations manages smooth running of clinical trials
Accountable for authoring end-of-study reports and publication of results
Other writing responsibilities may include: investigator brochures, clinical summary documents or other clinical components of regulatory submissions, answers to regulatory authority questions, abstracts, posters, presentations for symposia and conferences, manuscripts and clinical sections of IND and annual reports
Participates in review of analysis plan and advises on required tables
May contribute to setting up advisory boards including slide preparation, taking minutes and also slide preparation for FDA advisory committee
Develops and maintains effective working relationship and facilitates communication between Medical Monitor, Clinical Operations, Regulatory, Statistics and other groups as appropriate
Maintains an understanding of internal and external regulatory requirements relevant to provision of clinical documentation for regulatory files
Serve as an active matrix team member by providing guidance and direction to peer Medics and scientists to ensure the successful achievement of the Respiratory TA's goals and milestones
Actively participate in the development of scientific talent in the organisation. Provide guidance and coaching to team members

Clinical Scientist Resume Examples & Samples

Responsible member of the clinical team, dedicated to the development and execution of the clinical strategy and program (scientific, clinical, and operational)
Represent clinical trial team functions as an ad hoc member of Compound Development Teams for new Janssen Research & Development drug candidates
The clinical scientists primary responsibility is the execution and as such the Translational and Operational Implementation (trial set up/monitoring/oversight) of Clinical (Phase 1-2a) Study Concepts and Translational (Phase 0) Strategies of a selected molecular entity or translational paradigm in Experimental Medicine (Operational Leadership and Scientific knowledge)
The Clinical Scientist will be responsible (in concert with the Clinical Leader) to translate individual study concepts/strategies into study designs (outlines) and protocols (Scientific knowledge)
Contributes to and manages the development of the clinical development plan, Investigator’s Brochures, clinical study protocols, clinical study reports, regulatory documents, and other critical clinical study documents, etc for each clinically assigned project or program in close collaboration with Experimental Medicine Clinical Leaders and in partnership with supporting departments with Janssen Research & Development
Participate in Protocol Review Committee (PRC) and First-In-Human Committee meetings and incorporate the recommendations from these committees and from IRBs and regulatory agencies into study protocols
Assembles and co-chair clinical trial teams to coordinate the activities of clinical trial team representatives from supporting Janssen Research & Development clinical departments (Pharmacokinetics, Biostatistics, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, Biomarkers) to ensure all clinical study objectives are achieved
Accountable within EM NSC (TA) for the E2E execution process (from initial Protocol Elements Document [PED] to complete report) for each clinical assigned project (Phase 0 to 2a) in a timely and cost effective manner. The CS will act as the Therapeutic Area Single Point of Contact in relation hereto with all internal and external stakeholders. The CS manages the interactions with all partners (internal Janssen Research & Development departments and external contractors, investigators etc.) to facilitate successful conduct of Phase 0, 1 and 2a clinical trials
Plans, manages and monitors daily activities of each assigned clinical research project (Phase 0 to 2a) to ensure adherence to study protocol, GCP and J&J SOP requirements
Prepares bulk study drug forecasts and liaises with the Clinical Supply Team to ensure sufficient and timely delivery of Clinical Trial Drug Supplies
Liaises with bioanalytical laboratories, pharmacokinetic scientists, biomarker representatives and data managers to ensure key PK, PD and clinical safety data are available when needed for critical Clinical Team decisions
Liaises with statisticians and programmers to help develop and implement the statistical data analysis plans
Evaluates and selects clinical study research centers and appropriate investigators – in collaboration with Experimental Medicine Clinical Leaders (Phase 0 to Phase 2a), and the Research and Development Organization (Phase 1b/2a studies)
Provides clinical support for Regulatory Affairs activities for a clinical program (e.g., health authority documents/responses, labeling, filing activities)
Collaborates/assists with safety responsible physicians in medical monitoring and evaluation of adverse events in clinical trials
Contributes to the interpretation and reporting of clinical research results
Reviews/contributes to presentations, medical publications, etc emerging from the team and its affiliates
Negotiates and manages the budget for all project related activities (internal and external partners) of each individually assigned project
Participates on, and may lead, cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc
Reviews medical literature and related new technologies
May contribute to the evaluation of scientific opportunities in the therapeutic area
Master’s degree or PhD in a relevant field (e.g. Biomedical Sciences, Biology; chemistry; medical technology) , PharmD or MD degree from an accredited institution
At least 2 years of experience in clinical research that has exposed the individual to the rigors of human trial conduct with pharmaceuticals, devices, basic clinical practice with the precepts of Good Clinical Practice (e.g. Study coordinator; regulatory associate; data management specialist)
Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization desirable
Significant academic, pre-clinical or clinical research experience is especially desirable
A minimum of 2 years Drug Development or pharmaceutical industry (preclinical or clinical research) experience is required
Phase II/III development experience is an asset
Energy and enthusiasm are essential
Experience working in a Matrix environment is required
Up to 15-20% yearly travel is required (International as well as Domestic)
Willingness and ability to partially adjust work hours to facilitate trans-Atlantic collaboration
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Familiarity with key clinical research tasks, including: protocol authorship; trial execution; case report form design; data management and report writing
Good oral, written, and presentation skills
Good sense of cultural sensitivity and diversity
Demonstrated ability to manage multiple, diversified tasks concurrently and to prioritize tasks effectively
Ability to work under pressure to meet deadlines
An ability to handle complex projects and to overcome delays and obstacles
Good team member and interpersonal skills. The ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion

Principle Clinical Scientist Resume Examples & Samples

Lead the generation of study-related documents and/or contribute content and oversight of such documents, which may include, but are not limited to, reports of priors, investigational brochures, protocols, and case report forms
Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area
Review and critically analyze statistical analysis plans
Lead study level (and franchise level where applicable) publication planning
Generate documents to support regulatory submissions for SJM products and/or respond to questions from regulatory authorities about existing submissions
Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
Active participation as a core team member and subject matter expert in the Clinical Analytics group
Data integration across platforms and knowledge transfer from pre-clinical experiments to clinical trials
Contribution to planning and execution of collaborative projects with leading academic and commercial research groups worldwide
Develop global regulatory strategy for medical products
Attend, present at, and leads meetings with FDA
Mentor junior team members
Minimum qualification for this position is a Master’s degree in a relevant science with at least
8 years of relevant work experience
Previous experience working in a highly matrixed and geographically diverse business environment
Requires strong verbal and written communication skills, presentation skills, and interpersonal skills
Ability to lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
Ability to synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area
This position also requires strong leadership skills as it will require significant interaction with executive leadership, physicians and regulatory authorities
This position will require some travel
A Ph.D. in a relevant science

PD Clinical Scientist Resume Examples & Samples

Cross-Functional Team Membership
Participates in the relevant Clinical Science Team (CST)
Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
As requested, supports the CST lead and overall team with training new CST members
May also, as appropriate, support relevant sub-teams in training new team members
Global Clinical Development Planning

Clinical Scientist Resume Examples & Samples

Representing Clinical Development as a core team member on the Clinical Trial Team
Providing a clinical review of study-specific documentation and training materials
Performing clinical data reviews
Assessing reported protocol deviations
Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigation sites in collaboration with the Clinical Trial Team

Clinical Scientist Resume Examples & Samples

Understanding of clinical research process from clinical program/trial planning to regulatory submission
Understanding scientific process, as well as medical and statistical concepts
Ability to contribute and collaborate with a team including proactive issue identification and resolution

Senior Clinical Scientist Resume Examples & Samples

Bachelor’s degree with minimum of 7 years’; or MS with minimum of 5 years’; or PhD with relevant career experience
Excellent oral (including presentation) and written communication,
Computer/ database management

Clinical Scientist Cardiology Informatics Chicago Resume Examples & Samples

A Ph.D. in Health Informatics or an MSc with 3+ years of relevant experience, ideally with a focus on medical imaging informatics in the diagnostic and interventional cardiology space
Understanding of clinical workflow and systems, with an emphasis on cardiology, developed through experience in working with caregivers in clinical environments and research experience in the design, development, and evaluation of clinical decision support applications for healthcare with knowledge of the principles of medical image acquisition and processing
Experience in combining image processing and text processing techniques, machine learning, and knowledge management methods within clinical systems; preferably in a Big Data setting using Hadoop, MapReduce, NoSQL, etc
Expertise in the use of controlled clinical terminologies and ontologies (UMLS, SNOMED, ICD, RadLex etc)
Software prototyping experience in a clinically oriented research environment, with programming experience at least in Java or C# / WPF / .Net / Python. Other useful technologies are Matlab, R or Tableau/ QlikView / Spotfire
Health information systems (EMR, PACS, HIS/RIS, CathLab XperIM, HL7, DICOM, EMR, etc)

Clinical Scientist Resume Examples & Samples

Act as a technical expert to help provide education in many areas of the business from related functions to senior leadership in an effort to manage through the needs of a constantly evolving clinical environment
Continue to facilitate the incorporation of additional countries into the global model, meeting OUS requirements is critical
Responsible for re-evaluating clinical processes to keep in accordance with the new Medical Device Regulation (EU MDR) and MedDev 2.7.1 Revison 4 requirements and adjust accordingly
Responsible for reviewing inputs to clinical evaluations, searching for and reviewing of journal articles and technical documentation and handling various medical writing assignments
Collaborate with project teams to ensure the compliance of the new requirements and help provide suggestions on how we can satisfy them
Must become familiar with Windchill Design History Files (DHFs) and how to access the necessary information
Minimum of a Bachelor’s degree, Masters or PhD in a scientific discipline is preferred
Minimum of five years of relevant industry experience
American Medical Writing Association (AMWA) certification or equivalent a plus
Knowledge of statistical concepts and techniques
Knowledge of research methodology and clinical study design
Familiarity with medical device regulatory guidance and current policies on healthcare professional interactions
Excellent customer service orientation, written and oral communication skills and attention to detail required
Experience in a team based work environment. Working experience of personal computer systems and desktop office applications

Microbiology Clinical Scientist Resume Examples & Samples

Coordinates complex studies at multiple sites involving teams of Clinical Scientists
Prepares clinical trials, including: selecting and qualifying sites, negotiating contracts, designing studies, writing trial plans and protocols, setting up, equipping and training sites
Conducts and monitors clinical trials, coordinating all contacts with the sites, as well as building and maintaining relationships with investigators and the sites in connection with project
Master’s Degree in a scientific field with clinical emphasis and minimum 5 years of industry experience, of which 2 should be in a clinical lab (experience using IVD products) and 3 to 5 years’ experience conducting clinical trials
Or PhD with minimum 2 years of industry experience with clinical exposure
Experience with negotiation in English
Problem Solving/Judgment/Conceptual and Analytical Thinking, Relationship building, Innovation and Flexibility
Scope and Resources Accountability: Responsible for trials with complex protocols, which require specific technical knowledge, requires the ability to negotiate with investigators/doctors
Provides guidance and advice to more junior level Clinical Scientists and Project Teams
Key Performance Indicators (KPIs): Successful completion of trials with low level of deviation from protocols; Successful problem solving with minimal consequences to project timelines or product success
Timely and accurate reporting of trial progress with no surprises to Project Team
Key Contacts (internal/external) and Interfaces: R&D; RA; Project & Quality Management; Project Teams; Project Managers; Clinical Investigators & Evaluators

Clinical Scientist Resume Examples & Samples

Responsibility for review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, may be responsible for oversight of study enrollment and overall timelines for key deliverables
Contributes to design, analysis, interpretation and reporting of scientific content of protocols, investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents
May be asked to contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development plan in collaboration with matrix team members
Participates in opinion leader interactions related to the disease area(s); partners with Research, Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies
Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
Bachelor’s/Master’s degree in Science, Nursing or related to field with 11+ years of experience in the pharmaceutical industry or PharmD/PhD with 1+ years

Clinical Scientist Resume Examples & Samples

In collaboration with the Medical Expert and CTT, manage the ongoing medical/ scientific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Data Manager, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner
Responsible for the Clinical Study Report writing and publication of studies, either directly contributing to and managing the report writing, or by liaising with the medical writing/narrative group to ensure report is completed according to current requirements
Responsible for the set up and maintenance of the Trial Master File (TMF) for studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines
Contribute to the evaluation of clinical sites and external service providers perform-ing TM studies in healthy volunteers
Responsible for the coordination of pre-audit activities for nominated projects
Oversee the work of assigned support Clinical Trial Associates(s), ensuring clear delegation /assignment of duties are documented
Track record of successfully managing multiple Phase I and IIa clinical trials concurrently
Office and clinical trial software IT computer liter-acy
Operational project management experience in-cluding excellent planning, prioritization, problem solving and organizational skills. Used to manag-ing multiple priorities
Customer orientation awareness and focus

Laboratory Clinical Scientist Resume Examples & Samples

Valid California State Department of Health Services Clinical Laboratory Scientist License
Bachelor’s degree in Medical Technology or equivalent
Ability to learn and utilize computerized patient care management system

Clinical Scientist Resume Examples & Samples

Ensures a general clinical approach with highest ethical and compliance standards in which patient safety and data accuracy are put first and considered as the highest goods
Participates in various communication activities of the Medical Affairs department with internal and external customers (Relationship Management)
Participates the development and availability of contents relevant to Medical Affairs (evidence reports, teaching material, patient letters, summaries, etc)
Coordinates and participates in Medical Information Center activities (device inquiry responses)
Participates in the grant processes; including grant applications, facilitate grant analysis and execute decisions by grant committee, and assure accurate and timely close-out of the grant process
Establishes and maintains good and effective working relationships with the Company’s WW Medical Director, clinicians, scientists, core-labs, clinical consultants, and internal clients
Participate in budget activities, and interfaces with internal/external clients, as necessary, to ensure timely and accurate accruals
Supports the creation of scientific publications and presentations by implementing publication policy, coordinating with medical writers, providing clinical data and logistic support including investigator communication
Shares accountability with others for a positive team spirit that is characterized by mutual support, understanding, encouragement, and an active exchange of new ideas
Contributes to the creation and revision of regulatory annual reports (ARs) and clinical evaluation reports (CERs)
Expert knowledge of patient care and cardiovascular procedures
Operational processes, project management skills
Knowledge of healthcare ethics and compliance regulations
Oral and written communication skills to various audiences. Effective writing for various reports and purposes
Maintain professional and scientific integrity
Strong work ethics and commitment to serve internal and external clients
Energy, focus, motivation, debate-friendly, and good interpersonal skills
Open and honest approach to scientific debates and constant evaluation
Team player, “can-do” attitude
Ability and desire to develop good working relationship internally and externally

Clinical Scientist, MR Resume Examples & Samples

Collaborates with medical doctors in Chinese hospitals in evaluating new clinical applications for Magnetic Resonance
Assist customers in Chinese hospitals/universities/other research institutes to develop and publish HQ papers on conferences and journals
Advise colleagues in Product marketing and Applications on new technical and clinical developments, assists in writing commercial and technical documents
Advise colleagues in Sales and Service department on new clinical and technical developments
Regularly visit Clinical Science sites in China; discuss innovations with medical doctors

Senior Clinical Scientist Resume Examples & Samples

Writes and presents well-reasoned reviews and proposals to cross-functional project teams
By collaborating with interdisciplinary teams, develop and optimize REGN’s indication knowledge base/dashboard to facilitate information sharing across the organization
Assists in the development of portions of key documents for clinical programs
Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engages in team discussions and provides translational sciences support for assigned projects
Outstanding communication skills, both oral and written

Clinical Scientist Resume Examples & Samples

Technically competent
A professional attitude and conduct, the ability to communicate at different levels of education, including the ability to converse clearly and concisely one-on-one with physicians, and maintain composure under pressure
Competent Microsoft Office computer skills
Ability to comfortably work independently and troubleshoot technical issues (preferred)
Experience in the specific, high complexity clinical specialty (preferred)
Bachelor’s degree in medical technology; clinical laboratory; chemical, physical or biological science (preferred)
State of Florida Medical Technologist Licensure in the required specialty: If in Cellular Therapy (2990) – Any one of the following Hematology, Immunology, Molecular Pathology, Serology, Microbiology or Clinical Chemistry
If in Thrombosis Research (5580)- Hematology, Immunology and Molecular Pathology (ALL Required)

Temp-senior Clinical Scientist Resume Examples & Samples

Conducts detailed analyses of clinical data. Must be resourceful and have outstanding abilities to synthesize and make connections
Helps to author the Clinical Study Protocol, amendments and related documents, Informed Consent Form, monitoring plan, and other key study documents. Train and support CRAs/CROs on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility
Participates in development of other key documents and reports for clinical programs
Contributes to decision-making and provides well-reasoned, thorough reviews, due diligence and proposals to cross-functional project teams. Engage in team discussions and provide translational sciences support for assigned projects
Conducts detailed literature reviews and analysis of competitive landscape from a technological, mechanistic, pharmacological and clinical development perspectives. Based on scientific understanding of technologies, diseases processes and targets of interest, provides analyses and rationale for early clinical development opportunities
Contributes to the development and optimization of the REGN’s indication knowledge-base to facilitate information sharing across the organization

Clinical Scientist, Clinical Development Resume Examples & Samples

Development of clinical protocols and amendments, investigator brochures, and clinical study reports
Contribute to the strategic development of early and late stage clinical programs
Lead clinical study teams and provide appropriate medical monitoring for ongoing clinical studies
Evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
Prepare manuscripts, abstracts and presentations for scientific meetings
Conduct literature reviews and prepare summaries to support clinical development programs
Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
MD, MD/PhD, PharmD, Advanced Practice Nurse, or Physician Assistant
Clinical oncology experience; Board Certification in oncology or hematology preferred
1-2 years’ industry experience in oncology drug development preferred

Clinical Scientist Resume Examples & Samples

Support global objectives of Clinical Development and Head of Clinical Serology in VBU in every aspect of clinical sample testing. This includes but is not limited to reviewing clinical trial lab manuals, preparing Serology Plans to meet the endpoint objectives of each trial, following clinical samples through delivery to bio-analytical vendor, testing, data transfer and long term storage
Actively participate and represent the objectives of Serology and Clinical Development in clinical trial group meetings with the responsibility to follow the big picture and know what impact timeline issues in other groups will impact serology timelines, and also proactively inform other stakeholders when serology timeline changes may impact their activities
Comprehend and translate complicated scientific information in a way that can be utilized by nonscientific members of the clinical trial team
Interpret objectives of other matrix team members in the clinical trial and initiate discussions and collaboration so that what could be conflicting timelines and goals lead to the successful accomplishment of overall study objectives
Drive the drafting and responsible for execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans
Lead sample management for the clinical study beginning with oversight of shipment conditions and timing from the clinical site to the central laboratory, delivery of samples to the bio-analytical vendor, testing, reconciliation, data transfer, and final long term storage or further use approval of clinical samples
Oversee and manage the serology budget of clinical sample testing for all studies of the program
Oversee the review and execution of the Lab Manual, provided by the contracted central lab vendors, to guarantee proper sample management. Partner with Clinical Delivery project manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines
Inform Quality Assurance team on any quality deviation of sample management and clinical sample testing
Actively collect, interpret and review and document the above quality deviations for clinical sample handling or testing in the appropriate QA system
Oversee all timelines of clinical assays: from the development and validation of assays to the delivery of QC/QA results of clinical sample testing to Statistic and Data management. Provide regular updates to clinical teams on status and timelines
Oversee the trial master file (TMF) documents owned by serology in accordance with regulatory requirements and the Takeda Quality management system
Clearly document any changes to the clinical trial assay plan with analytically interpreted risk management assessment of impact to data and overall clinical trial outcomes. Understanding and ability to communicate justification for changes a high priority

Clinical Scientist Resume Examples & Samples

BS/MS/PhD (Advanced degree preferred) with a minimum three years of industry experience
Subspecialty training in oncology and/or hematology preferred
Outstanding academic achievement and significant clinical trial experience preferred
Demonstrates effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
Demonstrated independence, initiative and ability to work well in a fast-paced dynamic environment
Ability to travel (approximately 15% ) to investigative sites, regulatory agencies, and to attend major oncology meetings

Clinical Scientist Resume Examples & Samples

Medical Doctor with at least 5+ years of post-graduate experience in a hospital or related field in the clinic treating in oncology or one of the neurosciences (psychiatry or neurology preferred). Experience in biotech/pharmaceutical industry would be an advantage
Familiarity with medical literature and conduct of global clinical trials as well as knowledge of GCP/IHC, and regulatory/therapeutic guidelines
Ability to write rapid reviews of a specific indication through assessing medical literature
Excellent interpersonal, communication and presentation skills
Strong attention to detail, good organizational skills, prioritization, and time management proficiencies
Ability to work on multiple projects simultaneously
Excellent English language skills
Highly proficient in standard computer software (Word, Excel and Power Point)

Global Principal Clinical Scientist Resume Examples & Samples

The position holder contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan. This includes authorship/ review of some clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program
Contributes to the clinical oversight and medical guidance in collaboration with the team Principal/SeniorClinical Scientist, and (Senior) Global Clinical Program Directors during the conduct of the study
Liaisons with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators
Assists with the planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, Ad Boards etc.)
Manages the processes required to support external study review committees; e.g. data

Clinical Scientist Resume Examples & Samples

Significant experience in the advanced specialty testing of the appropriate subsection, and will demonstrate considerable technical and troubleshooting skills
Exhibit a professional attitude and conduct, possess the ability to communicate at different levels of education, be able to maintain composure under pressure, be flexible enough to accommodate rapidly changing priorities, and be capable of performing multiple concomitant assignments in a timely manner
Able to work independently, to implement new ideas where appropriate, and be able to fully research, troubleshoot and report on technical issues
Possess the ability to deal with personnel issues as required in an intermediate supervisory position
Evidence of supervisory skills, both from a personnel aspect as well as a technical aspect
Evidence of independent decision-making, answering technical questions and troubleshooting technical problems with consummate ease
Ability to clearly and promptly report back on findings and issues
Bachelor’s degree or equivalent in Clinical Laboratory Science
At least three years experience in a licensed clinical laboratory, performing the advanced high complexity tests in the appropriate subspecialty, to a constant high standard
If in Thrombosis Research (5580) – Minimum of six (6) years high complexity testing of which at least 3 years is in the appropriate subspecialty performing coagulation testing to a constant high standard
Demonstrable computer skills, with specific competency in computer software applications including Microsoft Outlook, Excel, Word, Access, and PowerPoint. Additional experience in statistical analysis is an advantage (preferred)
Evidence of good technical troubleshooting skills (preferred)
Experience in academic or clinical research (preferred)
Previous supervisory experience, both personnel and technical (preferred)
Florida State Medical Technologist Licensure in the appropriate clinical laboratory subspecialty (Hematology, Blood Bank)

Clinical Scientist Resume Examples & Samples

Provide operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports
Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Lead
Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations
Represent Vertex to outside personnel in the development of clinical protocols and study conduct
Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors
Support preparation of scientific material for conference presentations or publications
Collaborates with cross-functional groups at Vertex for assigned studies
Performs other duties as assigned related to clinical programs
Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
Ability to make independent, timely and appropriate decisions
High level of organizational and project management skills
Flexible to accommodate changes in team and project needs
Experience working with clinical trial sites

Clinical Scientist MR Resume Examples & Samples

Ph.D. degree in physics, chemistry, biomedical engineering or other relevant technical background (candidates with M.Sc. degree in above mentioned areas, complemented with at least 5 years of relevant experience in MR might qualify based on individual skills, publication record and personality)
Doctoral thesis or series of scientific publications on MR related topic
Experience in a clinical environment
Experience of clinical application of MR in a hospital environment would be advantageous
Proven computer-programming skills. Language C++ and matlab are desirable
Proven writing and teaching skills
Highly communicative to members of multidisciplinary team with various skill sets
Strong analytical and experimental skills, independent problem solver
Languages: fluent Dutch and English in writing and speaking
Prepared for frequent traveling
Experience on Philips MR systems would be highly desirable

Clinical Scientist Resume Examples & Samples

Initiate 'Clinical investigation studies' for feasibility and 'post-market clinical studies' to gather scientific evidence for publications using state of the art protocols and study designs, in close collaboration with marketing on the required proof points
Manage a network of Key Opinion Leaders and clinical sites
You have an MD, Masters and/or PhD degree in biomedical sciences, with clinical trial research experience in a hospital environment and/or a minimum of 1 year work experience in the industry
Strong leadership, creativity, and analytical capabilities
You are a team player and a coach. You have a ‘hands-on’ approach and good communication skills and are able to communicate well with all stakeholders (Physician investigators, Marketing, Clinical Science, Suppliers, and Development etc)
You are willing to travel abroad to visit Hospitals and congresses

Senior Clinical Scientist, MR Resume Examples & Samples

Above 3 years industrial (or clinical R&D) experience in Magnetic Resonance
Strong communication skills (clinical and technical) and teamwork
Good writing skills (Chinese and English)

Associate Clinical Scientist, MR Resume Examples & Samples

MS or PhD degree in medical science, biomedical engineering, physics or other relevant technical background
Experience in clinical study set up and execution
Can create trust, build and maintain relationships, connect and inspire
Strong problem solver capability and business orientation
Strong capacity to learn and apply advanced knowledge

Senior Clinical Scientist Resume Examples & Samples

Preferred with solid experience in various medical image processing algorithms in segmentation, registration or pharmacokinetic models; C++, Matlab experience are highly appreciated
Willingness to travel within your specified geographic region as well as nationwide
Strong in reading English literature and writing SCI papers, good communicate skills in English
Demonstrated interpersonal & communication skills Proven professional business acumen (experience interfacing with both internal team members and external customers as a part of a solution-based sales process)
Radiological experience in large hospital/university setting preferred, medical industry related work experience preferred

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