Clinical Research Scientist Resume Samples
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Clinical Research Scientist Resume Samples
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BH
B Hartmann
Berenice
Hartmann
2653 Rebekah Walks
San Francisco
CA
+1 (555) 889 8858
2653 Rebekah Walks
San Francisco
CA
Phone
p
+1 (555) 889 8858
Experience
Experience
Detroit, MI
Clinical Research Scientist
Detroit, MI
Haley, McClure and Braun
Detroit, MI
Clinical Research Scientist
- Adhering to key performance indicators for clinical study development, conduct, and reporting
- Provide management to the clinical research scientists to ensure that their role and contribution is optimized. Lead a cross functional team
- Work closely with Clinical Operations and Clinical Development
- Assists Scientific Director and/or Disease Lead in making recommendations, taking action and providing medical input related to medical affairs projects
- Attend professional meetings and congresses, as relevant, to support and represent early development compounds and development
- Work with the Medical Monitor and compound leader in preparation for, and organization of, translational development advisory boards
- Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock
Los Angeles, CA
Associate Clinical Research Scientist
Los Angeles, CA
Schmidt, Ullrich and Koelpin
Los Angeles, CA
Associate Clinical Research Scientist
- Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc
- Clinical study report preparation
- Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc
- Oversee and challenges the adequacy of planning for study implementation
- In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
- Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
- Participate and present at investigator meetings
present
Boston, MA
Senior Clinical Research Scientist
Boston, MA
Bruen Inc
present
Boston, MA
Senior Clinical Research Scientist
present
- Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
- Uses the Danaher Business System and standard work to systematically measure/report/improve the overall clinical study process
- Assist in establishing project budgets
- Participate in Development Planning for assigned compounds
- Prepare or assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc
- Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
- Assist in document template design and SOP writing
Education
Education
Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Life Sciences
University of Washington
Bachelor’s Degree in Life Sciences
Skills
Skills
- Strong attention to detail
- Ability to assimilate technical and scientific information quickly
- Proficient in clinical and scientific data review and analysis. Strong leadership, planning and organization, written and oral communication skills
- Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
- - Ability to assimilate technical and scientific information quickly
- Demonstrated ability in utilization of advanced methods, techniques, and procedures in the performance of scientific research involving multiple variables
- - Knowledge of clinical trial design, basic statistics, and data review tools
- Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Access, Excel, and PowerPoint)
- Knowledge of clinical trial design, basic statistics, and data review tools
- Demonstrated ability in oversight of standard sub-projects as principal researcher
15 Clinical Research Scientist resume templates
Read our complete resume writing guides
1
Clinical Research Scientist Resume Examples & Samples
- BS or BA with 1-3 years’ experience supporting clinical research or similar medical/scientific experience may be acceptable
- Demonstrated ability to identify study issues and implement solutions, including identifying and involving the appropriate decision makers
- Demonstrated ability to anticipate data needs and implement tools for effective study management
- Ability to achieve objectives and milestones
- Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
- Familiarity with Good Clinical Practices and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/or pharmaceuticals
- Willingness to accept challenging assignments and engage in relevant developmental activities
- Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
- Demonstrated ability to clearly and effectively communicate verbally and in writing
- High attention to detail and accuracy
- Proficient knowledge of medical terminology
- Experience with Microsoft Word, Excel, PowerPoint and familiarity with web-based applications
2
Clinical Research Scientist Resume Examples & Samples
- Bachelor’s degree required; RN, MS, Ph.D., or PharmD preferred
- 4+ years of experience in the pharmaceutical or biotechnology industry
- Proficiency in clinical and scientific data review, analysis, and data lock activities
- Comprehensive understanding of clinical trial protocols, Data Handling and Entry Guidelines, and CRF development
3
Clinical Research Scientist Resume Examples & Samples
- Assist the Clinical Research Scientist team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
- Review and query of oncology data including but not limited to: safety, primary efficacy variables, and laboratory data
- Assist with clinical document preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)
- Assist with clinical study report preparation to include narrative writing
- Participate in adhoc meetings
- Support clinical trial activities as requested
4
Clinical Research Scientist Resume Examples & Samples
- 3+ years of Technical and Operational experience in planning, executing, reporting and publishing clinical studies in industry
- Medical / Scientific expertise appropriate to program
- Knowledge and application of Statistical Analysis methodology and can identify trends and interpret / report data effectively
- Exceptional negotiation and conflict resolution skills
- Able to multitask efficiently and effectively
- Advanced Degree in Healthcare and/or Life Science
- Previous experience in Respiratory Clinical Research
5
Clinical Research Scientist Resume Examples & Samples
- Research clinical correlation between disease presentation and overall workflow, and outcome definition, to define ideal product solutions
- Build relationships with Key Opinion Leaders (KOLs) for collecting requirements during product and clinical development
- Scientific lead during development and execution of clinical studies
- Collaborate with key stakeholders in user environment such as physicians, nurses, and technicians to create new workflow and key product differentiators in terms of technical and clinical applications
- Research demographic distribution of clinical outcomes for initial products (example differences in Japanese and US markets), and how these learnings can be translated for broader adoption of Canon products
- Review scientific literature, clinical trends and retro-analysis of clinical studies to define hypothesis for clinical utility and market adoption
- Develop new methodologies and framework to maximize the adoption and usability experience of product concepts. For example, creating algorithms to provide solution for delivering the scientific results in a physician friendly manner
- Develop and maintain good working relationships with colleagues in R&D, Quality/Regulatory, Clinical, and other marketing functions
- Participate in hypothesis generation, product concept and clinical application definition, and key technical requirements
- PhD in Biomedical Engineering is required
- 3-5 years of research experience in Engineering and Medicine
- Experience in development of medical devices for clinical validation, in compliance with FDA regulations
- Excellent oral and written communication skills with the ability to communicate clearly to others in different functions
6
Clinical Research Scientist Resume Examples & Samples
- Research current clinical procedures, protocols, overall workflow, and outcomes, to define and support opportunity spaces of ideal product solutions
- Build relationships with Key Opinion Leaders (KOLs) as well as stakeholders in user environment such as physicians, nurses, and technicians to identify clinical needs and requirements during product and clinical development
- Explore/brainstorm broad range of creative solutions to address user needs
- Develop prototypes with engineers to explore methodologies and concepts to verify the proposed solutions and/or user experience by collaborating with key stakeholders in terms of technical and clinical applications
- Develop and maintain good working relationships with colleagues in Clinical, R&D, Quality/Regulatory, and other business functions
- Be the scientific lead during development and execution of clinical studies
- Create documentation for patent applications; review alternative technology as it relates to the invention
7
Principle Clinical Research Scientist Resume Examples & Samples
- Operating on behalf of the Medical Device Group, this individual will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects
- Participates in the development and delivery of appropriate Global EGS / EDS to support NPD and LCM within the assigned platform(s), with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment
- Delivering and leading on assigned clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP) , through effective partnership and engagement with the Clinical Operations and BSDM teams
- Ensuring input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS
- Leading study design activities in the development of appropriate clinical trials to meet the NPD / LCM needs
- Leading in appropriate interpretation, dissemination and integration of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, etc
- Contributing in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections
- Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc
- Foster strong relationships with external stakeholders to shape and influence relevant policies, etc
- Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
- Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, global clinical trial regulations, clinical trends and related healthcare market environment, and
- Ability to lead teams to deliver critical milestones, including complex projects
- Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). And to meet business objectives
- Understand team dynamics and demonstrate ability to build collaborative relationships with key internal and external partners and stakeholders
- Experience in effective management of project budget processes
- Bachelor’s degree in Biological Science or related discipline
- Minimum of 8 years related scientific / technical experience,
- Requires knowledge of Good Clinical Practices
- Excellent written, verbal and analytical skills with experience in working with cross-functional, cross-sector teams are required
- Leadership / management experience is preferred
- Clinical experience in the pharmaceutical/ medical device industry and or CRO is required
- Ability to travel 20% international and domestic
- New Product Development and Life-Cycle Management experience is required
8
Principal Clinical Research Scientist Resume Examples & Samples
- Reports to the Franchise Platform Leader or Sn Clin Res Mgr, MD CR&D
- Responsible for Clinical R&D activities for assigned projects
- Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment
- Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP)
- Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS
- Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs
- Lead in appropriate interpretation, dissemination and integration of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc
- Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections
- Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
- Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects
- Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations
- Comprehensive understanding of clinical trial regulations across multiple regions
- Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
- Change agent in team development and progression
- A Bachelor’s degree in Biological Science or related discipline is required
- An advanced degree is preferred
- A minimum of 8 years of related scientific / technical experience within clinical research is required
- A minimum of 5 years of leadership / management experience is preferred
- A demonstrable ability to provide strategic and scientific clinical research input across NPD and LCM projects is preferred
- A comprehensive understanding of clinical trial regulations across multiple regions is preferred
- An Ability to influence, shape and lead without direct reporting authority is required
- A successful track record of fostering strong relationships with external stakeholders to shape and influence relevant policies, etc is preferred
- Ability to 20% international and domesticClinical Research non-MD
9
Clinical Research Scientist Resume Examples & Samples
- Minimum 3 yrs. experience in oncology clinical development
- Proficient at data review and interpretation
- Experience in protocol development, study report preparation, CSR, Investigator Brochure preparation, regulatory submissions
- Full understanding GCP and ICH Guidelines
- Detail-oriented, well-organized
- Reviews data, recognizes missing/incorrect data and initiates missing data queries/data clarification queries to clinical sites including but not limited to: safety, primary efficacy variables, and laboratory data
- Review listings, lab reports, and subject profiles as defined within the Clinical/Medical
- Consult and troubleshoot issues with Data Management
10
Senior Clinical Research Scientist Resume Examples & Samples
- Prepare or assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc
- Review literature and prepare summary documents for inclusion in IB, protocols, Briefing documents, etc
- Protocol preparation (writing, reviewing and cross-functional facilitation as appropriate)
- Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data
- Clinical study report preparation
- Minimum 1-2 yrs. experience in medical or technical writing
- Knowledge of protocol design, implementation and proficient at data interpretation
- Experience in protocol development, study report preparation, Investigator Brochure preparation, IND
11
Senior Clinical Research Scientist, Immuno Resume Examples & Samples
- PhD, Pharm D., MPH, MS, or equivalent degree in life sciences or medically related field; prior immuno-oncology experience with check point inhibitors a plus
- Academic training in immunology a strong asset; working knowledge of current clinical use of checkpoint inhibitors or T cell engaging therapies highly valued
- At least 4+ years related experience in life sciences or medically related field, including at least 2 years of clinical development experience in Biopharmaceutical Industry
- Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussions with thought leaders
- Proficiency in scientific and clinical data review and interpretation
- Highly experienced in all aspects of the drug development process
- High level strategic thinking, critical thinking, problem solving and decision making skills
- Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
- Anticipates needs, assesses and manages business risks and organizational dynamics as well as their implications
- 10-20% Travel Required
12
Clinical Research Scientist, Immuno Resume Examples & Samples
- Oversee and challenges the adequacy of planning for study implementation
- Assist in establishing project budgets
- Participate on various corporate committees
- Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
- Minimum 2 yrs. experience in medical or technical writing
- Hematology/Oncology Experience
- Knowledge/exposure to allogeneic stem cell transplant or other cellular therapies preferred
- Extensive medical/scientific and clinical research knowledge
- Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
- EU Travel required
- Ability to assimilate technical and scientific information quickly
- Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project and JReview a plus
13
Clinical Research Scientist Resume Examples & Samples
- Perform literature search and data analysis to address research questions
- Support study physician(s) in the review and analysis of clinical trials data
- Assisting in database cleaning, and interpretation of results
- Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
- Prepare and review project and study documents including clinical trial protocols, clinical data listings, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
- In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct/metrics (enrollment, GCP practices, handling of safety issues, etc.)
- Adhering to key performance indicators for clinical study development, conduct, and reporting
- Individual contributor with specialized knowledge
- Presents concepts, facts, and reports and advises on key trends and issues
- Supports the planning, execution and reporting of clinical programs/trials
14
Clinical Research Scientist Resume Examples & Samples
- An advanced degree (PhD, PharmD, MD) in a related field
- Minimum 3 years of direct involvement with human intervention research
- A background in life sciences: psychology, neuropsychology, physiology, kinesiology, public health, epidemiology, or psychopharmacology
- Clinical study design, data collection, analysis, and data interpretation skills
- Experience interacting with clinical investigators and medical experts
- Excellent verbal, written, and interpersonal communication skills (fluency in English is required)
- Domestic travel (approximately <10%) is required
- Background in CNS diseases such as (MS, depression, schizophrenia)
- Track record of publications with human experimental research (clinical trials, psychological, physical activity monitoring, physiological etc…)
- Knowledge of or experience in industry clinical research
- Knowledge of or experience with ICH, GCP and relevant regulatory requirements
15
Associate Clinical Research Scientist Resume Examples & Samples
- Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
- Collaborates and supports operational activities as need be
- Participate in adhoc meetings (e.g. marketing)
- Lead team meetings as required
- Minimum 2 years experience in medical or technical writing
- Knowledge of Medical Terminology
- Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
- Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
16
Clinical Research Scientist Resume Examples & Samples
- Draft, review, and issue clinical study protocols and clinical study reports aimed at validating new products and product claims in support of regulatory submissions worldwide
- Work with multidisciplinary teams to design, prepare, and implement clinical plans, strategies, protocols, analysis plans, study reports, and publications
- Have the ability to understand, interpret and summarize the results of statistical analysis, and guide follow-up analysis for the Biostatistics group
17
Clinical Research Scientist Resume Examples & Samples
- Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years experience in clinical research development or equivalent
- Oncology experience (required) Hematology experience (plus). Protocol authoring (plus). Data review and medical monitoring of data (required)
- Minimum 5 yrs. experience in oncology clinical development
- Excellent written and verbal communication skills and interpersonal skills
- Knowledge of clinical trial design, basic statistics, and data review tools
- Proficient at data interpretation
- Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
- Demonstrated ability to work as part of a team
- Assist the Clinical Research Scientist team in the extrapolation and review of study data from the investigator sites
- Responsible for interacting with study sites to review, extrapolate, collect, study data, including, but not limited to, patient diagnosis, treatment plans/regimen, adverse event documentation and reporting, clinical response, and long-term follow-up
- May assist with designing data capture worksheets for investigator sites
- Reviews and verifies source documentation to determine accuracy and completeness of information and communicate discrepancies to clinical team for action resolution
- Adhere to standard operating procedures, protocols, and study specific guidelines
- Provide updates to clinical team as appropriate
- Participate in job related training and ad-hoc meetings
18
Clinical Research Scientist Resume Examples & Samples
- Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
- Work may include policy changes or recommendations
- Has an easily discernible impact on the job area and expected results
- Typically no cost center budget management responsibility
- MS or PhD
- Experience in Clinical Research methods and processes required
- Previous experience with Oncology Clinical Research studies is required. Position requires attention to detail, and medical knowledge would be beneficial
- Clinical Trial Design and Execution
- Clinical Development Planning
- Regulatory Management
19
Clinical Research Scientist Resume Examples & Samples
- Participating in and providing clinical input into safety and regulatory interactions
- Develops statistical plans and performs preliminary and exploratory data analysis of completed clinical trials
- Participates in the development of clinical operating guides and maintains secure study files
- Work closely with Clinical Operations and Clinical Development
- Collaborate with and provide leadership and mentoring to clinical study teams
- Provide clinical/scientific input during the development and execution of clinical trials
- Provide clinical/scientific input into, author sections of, and QC study-related documents (e.g. study concept documents and protocols)
- Participate in safety assessments
- Review and provide clinical scientific input to TLGs and safety narratives
- Initiate database analyses to support clinical objectives
- Contribute to the preparation of clinical study reports and regulatory submissions
- Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc
- Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by the Clinical Scientists, NAML, or GDL
- Comply with company regulatory, safety and compliance procedures and practices
- May be assigned other projects and duties as required
- PhD/MS/BS degree in a relevant scientific area; in depth understanding of immunology
- 8+ years directly relevant experience in the biotech/pharmaceutical industry including analysis of Oncology Trial data
- Prior Medical Monitor and Clinical Trial Management experience strongly preferred
- Prior experience in leadership roles for clinical study teams
- Understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics
- Proven scientific leadership when working with collaborative, multi-functional teams
- Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders
- Working knowledge of clinical database systems
- Solid medical/scientific writing skills; ability to effectively communicate across the business organization
- Ability to collaborate and work effectively in cross-functional teams within a complex matrix environment
- Knowledge of clinical research operations, including interpretation and implementation of cGCP, FDA regulations, and ICH guidelines is required
- Able to deal with time demands, incomplete information or unexpected events
- Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines
- Ability to travel over night
20
Clinical Research Scientist, General Medicine Resume Examples & Samples
- Three (3) or more years of clinical research experience and/or academic research experience including experience working on clinical trials
- Plus > 2 year experience in study site-monitoring
- Proficiency understanding the clinical strategy for products in the relevant therapeutic area
- Vendor management experience (preferred)
- Ability to provide scientific expertise to a clinical development program
- Operational excellence: self management skills, planning, prioritization, objective setting, meeting management, plan execution
- Interpersonal skills: ability to engage with key stakeholders at a professional and clinical level
- Language proficiency in both Japanese and English (business discussions, reading, and writing)
21
Senior Clinical Research Scientist Resume Examples & Samples
- A minimum of a Bachelor’s Degree with at least 6 years of clinical or related technical experience is required
- A Master’s degree or PhD/MD/PharmD is preferred
- A Life Science, Physical Science, Nursing, or Biological Science degree is preferred
- Knowledge of Good Clinical Practices is required
- Understanding and application of regulations and standards applied in clinical areas is required
- The ability to influence others along with strong written and oral communication skills is required
- Advanced project management skills with the ability to handle multiple projects are preferred
- Medical device experience is preferred
- Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE).Clinical Trial Administration
22
Senior Clinical Research Scientist Resume Examples & Samples
- Experience in protocol development, study report preparation, Investigator Brochure preparation, IND safety updates
- Experience in allaspects of the drug development process
- Limited travel required
- Ability to assimilate technical information quickly
23
Clinical Research Scientist, Biomedicines Resume Examples & Samples
- Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
- Candidate’s selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
- Rheumatology experience desirable
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
24
Senior Clinical Research Scientist Resume Examples & Samples
- An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
- 3-5 years of clinical experience or
- 3-5 years of pharmaceutical experience (2 of which is in clinical development)
- Experience in areas relevant to drug discovery
- Clear evidence and documentation of candidate’s direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
- Experience in rheumatology/PsA/AxSpA
- Knowledge of and networked with rheumatology thought leaders specializing in PsA/AxSpA preferred
- Fluent in English, verbal and written communication
25
Clinical Research Scientist Resume Examples & Samples
- Under minimal guidance, collect comprehensive pharmacokinetic information for potential drug candidates to be included into the company’s development program and to prepare Pharmacokinetic Evaluations if applicable
- Design BE studies, with the assistance of the Director of Clinical R&D, according to current standards and guidance applicable to conduct of BE studies/clinical studies
- Prepare and maintain the Sponsor Trial Master File (TMF) for each clinical study the Clinical R&D Scientist becomes responsible for
- Review clinical protocol and review and approve Informed Consent Forms (IFCs) and Case Report Form (CRFs) for BE studies/clinical studies
- Compile information in support of Clinical Trial Applications (CTA) and Import License applications and to send them to the concerned Clinical Research Organizations (CROs)
- Supervise and coordinate various study related tasks from study initiation to closure
- Arrange for handling, storage and retention of the Investigational Medicinal Products (IMPs), e.g. test and reference products
- Ensure that the IMPs intended for use in BE studies/clinical studies are labeled in accordance with Federal Regulations and local requirements where the study will be conducted
- Ensure timely shipping of the IMPs to the CRO/clinic site
- Ensure monitoring of BE studies and clinical studies when needed
- Monitor studies when needed
- Review and approve clinical study reports
- Respond to deficiency letters from authorities and audit comments
- Ensure that the timelines are kept for all tasks
- 2+ years related experience in the pharmaceutical industry
- Experience in BE studies/clinical studies is strongly preferred
- Functional Knowledge
- Experience with GCP, GLP and ICH guidelines and other guidelines applicable to conduct BE studies/clinical studies
- Strong Interpersonal and people skills, in particular the ability to build relationships and influence others
- Ability to plan, organize, coordinate, and manage tasks efficiently
26
Clinical Research Scientist Resume Examples & Samples
- PRE-REQUISITES: Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 7 years experience in clinical research development or equivalent
- Clinical monitoring experience preferred
- Experience in protocol development, study report preparation, Investigator Brochure preparation,
- Regulatory submissions
- Knowledge of GCP and ICH Guidelines
- Experience in presenting at Investigator Meetings
27
Clinical Research Scientist Resume Examples & Samples
- Analyze data and communicate research results to internal and external supervisors
- Document findings based and designed experimentation, conduct tests on biomaterials, including but not limited to sterile cell culture and proliferation assays
- Assist with animal studies, prepare scientific publications and maintain laboratory documentation, as well as support various cross-functional teams and business units
- Bachelors of Masters in Scientific discipline
- At least two to five years within lab environments, with preferred experience in biomaterial or orthopedic research
- Recent work experience related to mammalian cell culture or stem cell culture techniques
28
Clinical Research Scientist Resume Examples & Samples
- Represent Translational Development in cross functional teams/meetings (e.g. Project Teams, Study Sub-teams, Safety Review Committees and Management Teams, etc.)
- Support cross-functional sub-team meetings in collaboration with the Medical Monitor
- Oversee the preparation of a clinical development research plan (CDRP) that outlines the seminal summary data tables, figures, listings and patient profiles to monitor company-sponsored studies in collaboration with data management and clinical programming
- Work with the Medical Monitor and translational scientists in data preparation and review for Safety Review Committee meetings, Early Development Advisory Committee (EDAC) Candidate Development Committee (CDC) meetings, Quarterly Review meetings and various other internal and external meetings
- Work with the Medical Monitor and compound leader in preparation for, and organization of, translational development advisory boards
- Guide the Study Manager, CRAs, and others, in the day-to-day conduct of clinical studies from a clinical science perspective
- Attend professional meetings and congresses, as relevant, to support and represent early development compounds and development
- Actively engage/interact with key stakeholders, including: 1) 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; and 2) external: clinical investigators, study coordinators, advisory board participants
- Bachelor’s degree required; RN/PhD/PharmD preferred
- Minimal 5 years pharmaceutical/biotech industry or related experience; minimal 7 years experience for senior or principal CRS
- Previous experience in Clinical or Translational Development and proficiency in hematology and oncology disease indications required
- Working knowledge/familiarity with fundamental concepts in cancer biology as they relate to biomarker-driven early stage clinical trials
- Proficient in clinical trial protocol and CRF development and Clinical Study Report writing
- Proficient in clinical and scientific data review and analysis. Strong leadership, planning and organization, written and oral communication skills
- Proficient in industry-standard software (Microsoft Office Suite, electronic data capture, etc)
- Track record in establishing effective relationships with investigators and study staff
- Domestic and international travel, as required
29
Clinical Research Scientist Resume Examples & Samples
- Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information
- Serve as lead reviewer for physician-initiated studies for assigned therapeutic area
- Contribute to the optimization of internal processes and workflows
- Minimum qualification for this position is a Master’s degree in a relevant science
- Typically 8 years of clinical research or relevant work experience
- Prior experience working in a highly matrixed and geographically diverse business environment
- Requires strong verbal and written communication skills and interpersonal skills
- Prior leadership skills as it will require significant interaction with executive leadership, physicians and regulatory authorities
- A Ph.D. in a relevant science is highly desirable
30
Clinical Research Scientist Assistant Resume Examples & Samples
- Reviews literature and assists with preparation of key documents e.g. protocols, protocol amendments, Investigator Brochures, regulatory submission documents, internal or external presentations, etc
- Assist with the writing of Clinical Protocol and Informed Consent
- Assist with the organization and execution of study committees (i.e. Data Monitoring Committee, Scientific Steering Committee, etc)
- Contributes as a member of the Clinical Study Team
- Assist with organization of internal and external clinical meetings. Prepare and review presentations for meetings
- Assist the Clinical Research Scientist and Clinical Research Physician to interface with the project team members including Clinical Operations, Data Management, Biostatistics, Drug Safety, Regulatory, and Project Management
- Assist with preparation and organization of key documents e.g. Protocols, Protocol Amendments, Clinical Study Reports (and appendices), Regulatory documents, internal or external presentations, etc
- Participates and assists in the preparation of Clinical Study Reports
- Leads at least one Journal Review Session with Clinical Research Personnel
- Attend required trainings on GCP/ICH, company policies as well as other relevant trainings
- Other Assignments as determined by Manager and Mentor
- LI-EX
- Excellent verbal, written and communication skills
- Scientific & clinical research knowledge
- Ability to recognize potential problems and develop sound solutions
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Senior Clinical Research Scientist Resume Examples & Samples
- *Lymphoma experience highly desired
- Minimum 1 yrs. experience in medical or technical writing
- Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization
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Clinical Research Scientist Onc Resume Examples & Samples
- Extensive knowledge of Good Clinical Practices (GCP), HA regulations and guidelines, and international regulatory requirements/guidelines
- Experience planning and conducting epidemiologic studies/surveys (preferred)
- Experience conducting clinical trials in the relevant therapeutic area
- Proficiency in anticipating and resolving problems
- Experience writing and presenting clearly on scientific and clinical issues
- Experience leading teams in a matrix environment
- Professional collaboration and leadership skills
- Deep understanding of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and Policy
- Existing therapeutic area knowledge and demonstrated ability to rapidly develop deep understanding of new therapeutic areas
- Strong customer orientation; science based and marketing minded
- Existing network of OL contacts in therapeutic area
- Finance and budgeting experience
- Native level Japanese and business level English
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Clinical Research Scientist Hematology Resume Examples & Samples
- Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
- Participate in Development Planning for assigned compounds
- In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
- Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
- Assist in document template design and SOP writing
- Travel to investigator sites in the EU to assist in clinical management of ongoing studies; provides training as required
- LI-SL1
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Clinical Research Scientist Resume Examples & Samples
- Prepares and presents draft study synopsis, protocol, informed consent and clinical documentation associated with IND submissions. (Writing, reviewing, amending and cross-functional facilitation as appropriate)
- Provides input/guidance to Study Managers on scientific issues related to the operational aspects of the study
- Partners with Study Managers to ensure consistency across individual studies and programs with respect to key execution processes
- Reviews data and analyses on ongoing basis, in conjunction with the Clinician, including: safety data, primary efficacy variables, and lab data
- Prepares key documents such as Clinical Study Report, NDA/MAA submission, etc. in coordination with concerned functions (e.g., Medical writing, Regulatory, Biostatistics, etc.)
- Prepares and submits responses to Regulators during NDA review
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Clinical Research Scientist Resume Examples & Samples
- Data review and medical monitoring of data
- Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data
- Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)
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Associate Clinical Research Scientist Resume Examples & Samples
- Reviews literature and prepares summary documents for inclusion in IB, protocols regulatory submission documents, etc
- Assists Clinical Research Scientist and/or Clinical Research Physician in making recommendations, taking action and providing clinical research expertise related to projects
- Assists the Clinical Research Scientist and/or Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
- Prepares or assists with preparation of key documents e.g. protocols, protocol amendments, Investigator Brochures, regulatory submission documents, internal or external presentations, etc
- Assists in proofreading protocols for subsequent scientific review
- Prepares Clinical study report for required review
- Assists with organization and review of ongoing summary data including: safety, primary efficacy variables, and laboratory data
- Participates in KOL meetings
- Ability to initiate problem resolution with appropriate team members; seeks advice on more complex problems and understands when to escalate issues to Clinical Research Scientist and/or Physician
- Other duties related to the above within Celgene as a whole, as assigned
- Understanding of clinical study design and the drug development process
- Knowledge of protocol design, implementation and proficient in data interpretation
- Extensive medical/scientific & clinical research knowledge
- Knowledge of FDA regulatory requirements preferred
- Understanding of therapeutic area
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Principal Clinical Research Scientist Resume Examples & Samples
- Lead the implementation of the global Clinical Development Plan and lead the management of clinical study teams to meet corporate and clinical goals
- Lead the clinical disease team, which is responsible for the oversight of study teams for multiple company-sponsored studies in multiple global regions and which plays a key leadership role to ensure program and strategy development and execution
- Responsible for on-going review of key milestones such as protocol development, data review, site activations, enrollment, data-review, data-monitoring committee and scientific steering committee meetings, preparation of regulatory documents such as briefing documents, clinical study reports, and NDA’s and MAA’s, to ensure sufficient leadership and management to meet or exceed all program milestones
- Clinical member providing leadership and clinical input on global lymphoma project team. This includes primary interactions to lead and influence across multiple functions outside of the clinical group
- Responsible to ensure all clinical milestones and deliverables against strategy and programs are prioritized for project/study timelines to ensure adequate staffing for execution across departments (e.g. data management, drug supply, clinical operations, drug safety)
- Key clinical lead in cross-functional and clinical meetings, e.g., investigator meetings and ad hoc meetings (e.g. marketing) and various corporate committees, and in interactions with key investigators in disease area
- Responsible for Development Planning for assigned compounds aligned with the lead clinical physician
- Lead the preparation of key clinical documents e.g. Investigator Brochures, regulatory submission documents, clinical study reports, internal or external presentations, etc
- Responsible for the oversight of protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate) for all company-sponsored studies in a given disease program
- Responsible for the oversight of clinical data review of safety, primary efficacy variables, and laboratory data
- Responsible for managing Clinical Research Scientists in a disease area including development training, performance management, goal setting, etc
- Drive execution – Gets things done by setting clear expectations (goals), monitors progress, holds people accountable (appropriately based on their skills, ability and experience), rewards appropriately and follows up
- Create a global mindset – Develops an understanding of the international issue facing the business; appreciates how ethnic, cultural, and political matters influence business; integrates local and global information for decisions affecting multiple sites; applies knowledge regulatory frameworks in multiple countries; makes deliberate decisions about how to conduct business successfully in different parts of the world; recognizes the impact that actions in one country have on other countries; promotes cross-geography collaboration and cooperation
- Promote Open Communication – Create an environment where communication is expected, supported, clear, candid, transparent and relevant; listens actively and encourages open expression of ideas and opinions
- Demonstrated Adaptability – Demonstrates an ability to adapt appropriately to changing conditions – business situations, people and changing priorities; an ability to work constructively under pressure; an ability to respond resourcefully to change and ambiguity and learn from one’s mistakes
- Foster Risk Taking – Create an environment that encourages risk taking; demonstrates ability to take and manage appropriate risks and use them to the organization’s advantage
- Foster Teamwork – Foster an environment where people value each other and recognize the importance of each role in the organization; recognizes the impact of cultural differences and different time zones on teams; encourages cooperation, coordination and information sharing
- Must demonstrate leadership skills/capability
- Ability to work well in a cross functional environment
- Extensive clinical project management skills
- Experience in all aspects of the drug development process
- Excellent written and verbal communication skills; effective oral presentation skills
- Ability to effectively communicate in a global environment
- Demonstrated ability to effectively influence and motivate team members
- Knowledge of clinical trial design, basic statistics, pharmacodynamic & pharmacokinetics
- Extensive experience in protocol development, clinical study report preparation, Investigator Brochure preparation, regulatory submissions
- Understanding of Regulatory and Commercial activities
- Proficient in data interpretation
- Clinical monitoring experience a plus
- Proficiency in Microsoft Word, Excel, PowerPoint; Microsoft Project a plus
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Clinical Research Scientist Resume Examples & Samples
- An advanced degree (Ph.D.) in a related field
- A background in life sciences, including but not limited to psychology, neuropsychology, physiology, kinesiology, public health, epidemiology, or psychopharmacology
- Background in CNS diseases such as schizophrenia
- Knowledge of or experience in late phase clinical research
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Clinical Research Scientist Resume Examples & Samples
- Liaise with study investigators, site research staff, and field based colleagues to support clinical studies. Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials
- Organize investigator’s start-up meeting and study site initiation meetings
- Drive study enrollment, plan advisory boards, and perform external study feasibility with investigators
- Patient Recruitment: track enrollment, develop trial awareness and recruitment plans, and ensure procedures are in place for appropriate optimization of patients into the clinical trial. Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs)
- Understand and comply with company SOPs and GCP’s; contribute to continuous improvement in SOPs and local Working Practices
- Plan the requirements for clinical trial (CT) material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby material is shipped to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary
- Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used
- Contribute to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency
- Support the development, management and tracking of trial budgets working closely with the appropriate partners
- Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment
- Manage the Contract Research Organizations – initial identification of a suitable partner, definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success
- Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with
- Support all scientific aspects of clinical trial(s) and program level activities as assigned
- Provide management to the clinical research scientists to ensure that their role and contribution is optimized. Lead a cross functional team
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Clinical Research Scientist Gastroenterology Resume Examples & Samples
- Prepare key documents for regulatory submission documents, study protocols and informed consents. This includes writing, reviewing, amending and facilitating cross-functional review as appropriate. Collaborate with Key Opinion Leaders as required
- Design and develop study protocols and informed consents. This includes writing, reviewing, amending and facilitating cross-functional review as appropriate. Collaborate with Key Opinion Leaders as required
- Contribute to the Clinical Development Plan (CDP)
- Assist the Clinical Research Physician (CRP) to make recommendations, take action and provide clinical research expertise related to projects
- Interface collaboratively with study team members, e.g. Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Leadership & Management
- Along with Celgene Study Team, provide relevant support to CRO in the management of clinical studies
- Actively participate and contribute to study/project team meetings
- Review scientific literature related to assigned clinical programs
- Provide scientific expertise to other departments and line functions
- Review and interpret study data as it relates to efficacy and safety
- Provide scientific input, review, and edits to clinical study reports, Investigator Brochures, narratives, INDs, NDAs, briefing documents, annual reports, and other regulatory submissions. May be called to assist in writing these documents
- Organize and provide training assistance to departments/vendors (scientific/development improvements)
- Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or endpoint-specific training for study protocols
- Assist with planning of, and participate in, Investigator Meetings and Advisory/Scientific boards. Prepare and present clinical data in these venues as needed
- Assist with budget projections for clinical activities (such as consultants, advisory board meetings, etc.) for assigned clinical programs
- Prepare DMC and/or adjudication charters. Prepare deliverables and participate in periodic review meetings
- Provide Clinical Management with regular study updates/status reports
- Perform other tasks as assigned by supervisor
- LI-AG1
- 5-7 years of biotech/pharma/CRO experience with at least 3 years in clinical research and development
- Bachelors degree required with a concentration in life science preferred. Masters degree, PhD or Pharm D. OR EQUIVALENT preferred
- Previous experience in immunology preferred; previous experience in Gastroenterology is a plus
- Proven medical/scientific writing skills
- Advanced analytical and influencing skills
- Knowledge of early and late phase clinical program development
- Expert understanding of global clinical study design and drug development processes
- Experienced in presenting at Investigator Meetings
- Able to multi-task
- Able to work independently, exercise sound judgment, and escalate issues when necessary
- Able to assimilate technical information quickly
- Able to work efficiently, and collaboratively, in a matrix organization
- Proficiency in Microsoft Word, Excel, PowerPoint is a must; proficiency in Microsoft Project, Visio, and electronic document repository system a plus
- High level of interpersonal and communication skills (written and verbal)
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Senior Clinical Research Scientist Resume Examples & Samples
- Accountable for the clinical execution of the study protocol
- Work with the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
- Author clinical protocols (writing, reviewing and cross-functional facilitation as appropriate)
- Prepare or assist with preparation of clinical sections for other key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc
- Review of ongoing clinical trial data including: safety, primary efficacy variables, laboratory data; and coordinate the internal/external data review meetings
- *Multiple Myeloma Experience preferred
- Extensive medical/scientific and hematology/oncology clinical research knowledge, multiple myeloma experience is a plus
- Direct experience in authoring clinical protocols, clinical study report and clinical sections of other related documents such as Investigator Brochure, PSUR/DSUR safety updates
- Experience working in clinical databases and with the application of data review tools for safety and medical monitoring of oncology/hematology studies; knowledge of design and implementation of case report forms
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Experience in managing outsourced clinical studies
- * some travel required
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Senior Clinical Research Scientist Resume Examples & Samples
- Design clinical studies for the purpose of assessing the performance of current products, of products under development or modification, and of competitors’ products
- Plan, perform, and manage off-site and on-site clinical studies
- Compile, analyze, and report results of clinical studies. With some supervision, draw conclusions from analyses
- Participate in development of new instruments and the improvement of existing instruments. Troubleshoot prototypes and current production instruments
- Maintain computer and statistical skills consistent with needs of position
- Maintain clinical competence with Carl Zeiss Meditec products
- Provide technical support to marketing personnel, answering customers’ questions, giving instruction in operation of Carl Zeiss Meditec products. Assist in the writing of users’ manuals and other publications
- Maintain knowledge of corporate guidelines for Good Clinical Research Practices and of IRB procedures
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Clinical Research Scientist Resume Examples & Samples
- 3 years of experience in developing and conducting scientific investigations and applying research principles, methodologies, and study design
- 3 years of experience in applying for and achieving grant funding
- Basic statistics (SPSS, SAS)
- Self-directed and motivated to work independently toward short- and long-term goals
- Demonstrated ability in utilization of advanced methods, techniques, and procedures in the performance of scientific research involving multiple variables
- Demonstrated ability in independent design, organization, and quality control of moderately complex but specific research projects within an integrated, multifaceted research program
- Demonstrated ability in oversight of standard sub-projects as principal researcher
- Demonstrated ability in direct participation in the development, writing, and presentation of abstracts, manuscripts, and posters as part of a research team
- Good communication, organization, critical thinking, and interpersonal skills
- Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Access, Excel, and PowerPoint)
- Knowledge of research regulations, methodology, principles, and procedures
- Knowledge of current technological developments/trends in area of expertise
- Evaluates, selects, and applies standard scientific techniques, procedures, and criteria to accomplish a variety of research assignments
- Makes preliminary selections and adaptations of scientific alternatives requiring the exercise of judgment
- Collects, analyzes, and interprets data
- Prepares statistical and narrative reports and/or graphs, including production of manuscripts and abstracts on selective projects for publication in scientific journals
- Serves as principal investigator and/or co-investigator on sub-projects of complexities consistent with above criteria
- Collaboratively and/or independently seeks funding sources and applies for funding to further the goals of the department’s research
- Designs, performs, and/or oversees experiments and data collection to ensure data integrity, quality control, and protocol compliance
- May manage operations and budget of a specific research unit
- Supervises, mentors, and guides staff and/or students engaged in associated research support activities
- Performs miscellaneous job-related duties as assigned
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Clinical Research Scientist Resume Examples & Samples
- Develop and/or help the US tumor leaders in creating and maintaining the IIT clinical scope document, including coordinating with relevant tumor teams and global product teams. He/she will be responsible for maintaining scope documents via semi-annual reviews
- Serve as the Initial point of contact with US Field Medical or clinical investigator for high level review and/or discussion for IIT proposals
- Coordinate with the IIT Project Management Consultant to drive customer service principles throughout the IIT review process, work in coordination to drive success within the IIT review process and study execution
- Collaborate with the IIT Project Management Consultant to ensure leadership is informed of successes and challenges throughout the IIT program
- Evaluate the scientific merit of IIT proposals and triage concepts and proposals based on the alignment to the scope documents for each molecule. Strive for quick responses to investigators for proposals out of scope and direct proposals within scope to the appropriate tumor team and/or GPT team for further review
- Review IIT proposals and publications, as requested by the US tumor leads or Sr Medical Director
- Participate in the Protocol Review Committee (PRC) as a PRC reviewer
- Participate, present and lead discussions at IIT review meetings as directed by US tumor team leads or Sr. Medical Director
- Maintain regular communication with medical partners to keep the team updated on IIT program changes and status of ongoing trials
- Serve as the primary point of contact with US Field Medical and/or investigators to follow up on clarifications or changes requested as part of the review process
- Work closely with the IIT Project Management team to ensure approved protocols have all modifications made prior to contacting
- Meet with key investigators to discuss proposals and protocols, as needed
- Identify and develop relationships with key research networks and/or collaborative groups of strategic importance with a priority to foster IITs with these prioritized networks / collaborative groups
- Identify and lead continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Ensure that any proposed changes align with the MQS Procedure on IITs and the associated Global IIT Review Committee Charter
- Maximize shared learning opportunities across tumor teams and global medical teams capitalizing on best practices
- Advanced medical related graduate degree preferred, such as: DVM, PharmD, PHD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR
- BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs
- 3+ years Oncology experience required
- Breast cancer experience is strongly preferred. Lung / Sarcoma / Gastric cancer experience also a plus
- Knowledge of drug development process preferred
- Interpersonal, organizational and negotiation skills
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
- Excellent teamwork skills
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Clinical Research Scientist Resume Examples & Samples
- Support the business unit management team, including medical leadership in preparation and administration of the local or business unit medical budget
- Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable
- Collaborate proactively and productively with all alliance, business, and vendor partners
- Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness
- Business / customer support (pre and post launch support)
- Scientific Data Dissemination / Exchange
- An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and priority will be if candidate has the following
- 1 - 4+ years of pharmaceutical experience (>1 of which is in oncology medical affairs / medical communication -or- oncology/thoracic field work)
- Excellent scientific communication, medical writing, interpersonal, teamwork, organizational and negotiation skills
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Associate / Clinical Research Scientist Resume Examples & Samples
- Acts as US trial leader in the management and conduct of several oncology clinical trials
- Responsible for the execution of trial timelines, meetings, milestones, resources, eligibility, enrollment and data flow/consistency in alignment with Global Clinical Development
- Creates working relationships with external site personnel and internal team coordinating activities across functions (investigators, study coordinators, US Medical, Global Medical, CROs, etc)
- Assist in the writing of trial related documents (e.g. Informed consents) and support documents for national IRB submission
- Monitors and tracks trial progress and implements changes to ensure timely, quality deliverables
- Responsible for the content of trial related communication to internal and external customers (e.g. newsletters, site/CRA trainings, protocol training)
- Responsible for study documentation according to Novartis Oncology and FDA SOPs/WPDs and GCP/ICH guidelines, ensuring no major audit findings
- Addresses complex scientific trial related issues, particularly with biologic compounds, with internal and external customers
- Actively provides input in clinical trial protocols /reports and integrates feedback from internal and external partners
- Responsible for oversight of data management activities of a trial and works with the CRAs/sites to ensure timely resolution of data issues
- Assist in grant planning and financial approval/reconciliation of trial activities
- Will work with Novartis sponsored (Clinical Development) as well as Investigator Initiated(Medical Affairs) studies
- Minimum of Bachelors degree required, (scientific or healthcare related discipline is preferred) with at least 1-3 years of relevant pharmaceutical or healthcare experience desired
- Experience in clinical research involving biologic compounds
- Well organized and has the ability to multi-task
- Able to lead, manage and work in multifunctional teams
- Proficient presentation and communication skills
- Previous experience in clinical trial/project resourcing, methodology, processes and operations 8. Demonstrates effective interactions with appropriate levels of the organization and with an external audience
- Project management experience desired
- Knowledge of GCP and regulatory requirements
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Senior Clinical Research Scientist Resume Examples & Samples
- This position requires a minimum of an advanced degree in a scientific discipline (i.e. M.D. or Ph.D)
- 2-5 years of experience in a related clinical research position within the pharmaceutical industry. Significant knowledge of clinical research methods and processes is required and the application to cancer drug development is highly preferred
- Good oral and written communication skills are essential. Good presentation skills (including report development) are a plus but not a requirement
- Successful work experience in a matrix team environment with cross functional teams is required
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Acpru Clinical Research Scientist Resume Examples & Samples
- Review draft laboratory manuals and study protocols and provide comment
- Manage and maintain necessary laboratory supplies and equipment
- Ensure biomarkers are procured and processed per laboratory manual and study protocol following all applicable regulations
- Ensure all technicians processing biomarkers are qualified and trained on processing laboratory samples including biomarkers per laboratory manual and study protocol
- Manage shipment and receipt of biological samples and associated records
- Perform sample discrepancy resolution duties
- Maintain professional communication and interaction throughout all aspects of work at the ACPRU and with outside client groups. Is able to effectively communicate with all levels of AbbVie management
- Accurately comply with study protocol, laboratory manuals and SOP requirements and complete source data in PIMS or on source data worksheets. Is able to independently generate necessary source worksheets from study protocols. Ensure study documents are completed appropriately
- Prepare and present multiple project progress reports to update management and keep project teams informed
- Work independently as well as in a team. Mentor, coach and train Research Technician staff
- B.S. and 5 years relevant experience, or M.S. and 2 years relevant experience required
- Chemistry, biology and immunology background preferred
- Experience working under GLP/GCP regulation preferred
- High energy and a quick learner
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Senior Clinical Research Scientist Resume Examples & Samples
- Clinical study planning, trial design, trial execution and trial closeout in the field of clinical pathology. Examples of work deliverables include clinical evidence strategy, clinical protocol, data management plan, monitoring plan and clinical report
- Operational activities supporting these clinical responsibilities require strong cross-functional collaboration. Deliverables include: Study site qualification, site selection, site initiation, clinical study monitoring, evaluate clinical results, report generation and clinical evidence publication of trial results in peer-reviewed journals
- Represents the Clinical Affairs department on multi-functional core teams, and at FDA, to ensure program requirements are met and that clinical trials are executed in a compliant, scientifically appropriate manner
- Uses the Danaher Business System and standard work to systematically measure/report/improve the overall clinical study process
- Ensures adherence to Good Clinical Practice (GCP) global standards and department standard operating procedures for conducting device clinical studies
- Bachelor’s Degree 7+ years
- OR Master’s degree with 5+ years
- OR Doctoral degree with 3+ years
- Demonstrated experience in clinical strategy, study design/execution and study monitoring for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment
- Demonstrated knowledge and experience with the relevant global standards and FDA requirements for clinical trials
- Experience in oncology, IHC and/or ISH, or pathology imaging are highly preferred
- Hands-on experience with genomics and/or proteomics assay development is highly preferred
- Able to secure appropriate internal or external technical expertise required and coordinate efforts to resolve compliance or technical issues that may arise during clinical trials
- Ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities
- Demonstrated ability or track record of successful results
- Proven technical writing and presentation skills required
- Demonstrated ability to be flexible and resourceful. Excellent communication and diplomacy skills required
- Independent, motivated, organized individual with strong analytical and problem solving skills
- Strong computer skills, including demonstrated high proficiency with Microsoft Word, Excel and Powerpoint
- Strong interpersonal/communication, presentation and writing skills
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Clinical Research Scientist Resume Examples & Samples
- Assists Scientific Director and/or Disease Lead in making recommendations, taking action and providing medical input related to medical affairs projects
- Assists the Scientific Director and/or Disease Lead to interface with project team members including: Medical/Clinical Operations, Commercial, Data Management, Statistics, Drug Safety, Regulatory and Project Management
- Assists with review of data from ongoing MASTs and registries including: safety, primary/secondary efficacy variables, and laboratory data
- Assists with preparation of key medical affairs documents (i.e. tactics, ad board slides, etc)
- Responsible for completion of milestones associated with specific projects (as assigned)
