Director, Clinical Research Resume Samples

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EG
E Gislason
Enrico
Gislason
473 Ima Brook
New York
NY
+1 (555) 354 8475
473 Ima Brook
New York
NY
Phone
p +1 (555) 354 8475
Experience Experience
Detroit, MI
Director, Clinical Research
Detroit, MI
Rippin LLC
Detroit, MI
Director, Clinical Research
  • Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
  • Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
  • Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and
  • Leading the development of Clinical Protocols to meet CDP objectives
  • Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
  • Developing of clinical development strategies for investigational or marketed Oncology drugs
  • Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications
San Francisco, CA
Associate Director, Clinical Research
San Francisco, CA
Bogan LLC
San Francisco, CA
Associate Director, Clinical Research
  • Assist Senior Director, Clinical on developing of clinical program for projects
  • Develop study specific training documents and investigator’s brochures
  • Participate in the development of implementation of clinical trial documents
  • Manage CRO’s and other vendors; monitoring and audit activities to ensure studies compliance with GCP/ICH guidelines
  • Conduct monitoring and co-monitoring activities
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Lead all necessary activities including setting up, monitoring and reporting of bio studies
present
Los Angeles, CA
Director Clinical Research Operations
Los Angeles, CA
Smitham, Schumm and Schmidt
present
Los Angeles, CA
Director Clinical Research Operations
present
  • Provides direct leadership and management for PHC research operations team members
  • Continuously evaluates research program compliance, quality, and effectiveness, identifies, and develops opportunities for improvement that provide greater value for stakeholders
  • Leads process improvement and organizational change initiatives toward program optimization
  • Partners and collaborates with the PHC Compliance office to evaluate and address research compliance issues and risks
  • Encourages expanded participation from existing physician investigators through action oriented and expert support and helps to inspire and support new investigators in the sponsored research program
  • Organizes and structures PHC research administrative services to expand the capacity of the research program with a focus on increasing and diversifying sources of revenue and financial support
  • Directs an effective system of marketing and communication across PHC, the research community, and key stakeholders, to build and promote a positive image of PHC sponsored research
Education Education
Bachelor’s Degree in Relevant Life Science
Bachelor’s Degree in Relevant Life Science
Southern Illinois University Carbondale
Bachelor’s Degree in Relevant Life Science
Skills Skills
  • Ability to multi-task and manage several projects in parallel, paying attention to detail
  • Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance
  • Excellent oral and written English language skills
  • Strong project management skills
  • Good written and verbal communication skills
  • Knowledge of regulatory environment and guidelines (ICH, GCP and CFR)
  • Ability to resolve routine issues effectively and independently
  • Significant medical and scientific knowledge
  • Strong partnering and collaboration skills
  • Knowledge of Clinical Development Process
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15 Director, Clinical Research resume templates

1

Director, Clinical Research Otc Pain Resume Examples & Samples

  • Lead the medical and clinical aspects of new product development strategies and drive strategy implementation
  • Demonstrate expertise in clinical study design, protocol development and implementation of clinical studies
  • Demonstrate leadership skills and ability to manage complex processes and initiatives
  • Have strong analytical and qualitative skills and ability to synthesize data, draw conclusion and implications, and translate into comprehensive strategies and recommendations
  • Assist with safety monitoring/reporting of all company-sponsored research activities
  • Help explore and evaluate new product ideas to assist in identifying new marketing opportunities
  • Act as principal clinical liaison with all domestic and international regulatory agencies and external opinion leaders
  • Requires a Medical Degree (MD, DO or equivalent)
  • PhD or PharmD may be considered with considerable pain related clinical research experience
  • A minimum of 5 years of clinical research and/or medical affairs related industry experience is required
  • An active license to practice medicine in the US or Canada is preferred
  • Clinical experience and subject matter expertise in pain management and/or OTC experience is required
  • Strong technical and business leadership skills are required
  • Prior global industry experience and/or emerging market experience is a plus
  • Ability to function in situations that can have a high degree of ambiguity
  • May require up to 10% annual travel (domestic and international)Clinical Research MD
2

Director, Clinical Research Operations Resume Examples & Samples

  • Perform long-range planning and the deployment of critical administrative resources toward positioning the University of Arizona’s College of Medicine – Phoenix units to provide comprehensive and efficient support for clinical research
  • Work closely with the HIPAA office and Human Subject Privacy Protection Program for policy interpretation, investigations and corrective action plans
  • Implementation of a comprehensive clinical research training, education and professional development program for faculty and staff including subject recruitment, team communication, CRF submission, adverse event reporting, Good Clinical Practice
  • Oversee clinical research within our research units including overall operations, scheduling and staffing and strategic decisions
  • Excellent communication skills and ability to work with a wide range of people at all levels of the organization
  • Ability to understand and interpret laws, regulations and policies related to the responsible conduct of research and good clinical practice
  • Experience and knowledge of institutional compliance and federal regulations regarding care and use of animals
  • Demonstrated computer skills using Word, Excel, Outlook and PowerPoint
  • Direct experience in a clinical research environment
3

Assoc Director, Clinical Research Resume Examples & Samples

  • LI-RD2
  • PhD or MD-PhD with at least 10 years experience in applying imaging to drug development
  • Extensive technical and clinical experience in quantitative clinical imaging technologies, in areas such as, but not limited to, MRI, molecular imaging, CT, and ultrasound
  • Understanding of technology cycles and the ability to identify novel technologies and develop plans for practical implementation in an industrial research setting
  • Thorough understanding of next generation imaging technologies and those most likely to deliver impact
  • Evidence of impact through identification and championing of new scientific initiatives
  • Evidence of ability to problem solve and influence in complex experimental designs
  • Evidence of scientific leadership role with responsibility for research project delivery
  • Strong inter-personal relationship skills with ability to work in diverse teams
  • Demonstrated ability to provide technical expertise in a multidisciplinary scientific environment
  • Strong and effective communication skill
4

Director, Clinical Research Resume Examples & Samples

  • Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP
  • Leading the development of Clinical Protocols to meet CDP objectives
  • Serving as a Study Director and driving the execution of studies from protocol concept to final report including interpretation of clinical data
  • Willing to serve as a Medical Monitor and possibly, Study Director for a study or clinical program; including review and monitoring study safety data
  • Interpreting study data and developing integrated summaries of safety and efficacy
  • Contributing clinical expertise to regulatory documents (e.g., briefing books, INDs, NDAs, etc.). May represent Clinical in discussions with Health Authorities
  • Acting as a coach and mentor to staff members across the NBG unit
  • Setting key deadlines and project milestones for projects within the function
  • MD required; Sub-specialty training in Neurology or Psychiatry
  • A minimum of 5 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies
  • Strong interpersonal and leadership skills; demonstrated ability to build consensus and drive change in a matrix environment with cross functional teams
  • A thorough understanding of clinical research methodology including study design, protocol writing, and study report preparation
  • Comprehensive understanding of GCP of local regulatory requirements
  • Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience
  • Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action
  • Previous participation in the selection of new compounds for clinical development and IND filing in neuroscience through technical evaluation of licensing and/or partnering opportunities
  • Solid understanding of the drug development process based on experience gained in the pharmaceutical or biotech industry
  • Excellent oral and written communication and presentation skills
  • Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects preferred
  • Experience with pediatric and epilepsy studies is a plus
  • Annual travel required may be up to 10% (domestic and some international)
5

Director, Clinical Research Resume Examples & Samples

  • Directs and implements clinical research plans and programs according to established design principles
  • Directs the integration of the Clinical Development Plan (CDP) and the Drug Development Plan
  • Leads the development of Clinical Protocols to meet CDP objectives
  • Serves as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data
  • Serves as the Medical Monitor for a study or clinical program, reviews and monitors study safety data
  • Implements strategies to identify, monitor and resolve clinical/program trial issues
  • Serves as the clinical/medical team expert to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), and identifies and liaises with KOL regarding program strategy and scientific advice
  • Interprets study data and develops integrated summaries for safety and efficacy. Contributes clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
  • May represent Clinical team in discussions with Health Authorities
  • Sets key deadlines and project milestones within function
  • Makes appropriate budgetary allocations to targeted opportunities
  • Reviews 3rd party (contractors, consultants and vendors) work product an deliverables to approve payment of invoices and resolves issues
  • Leads by example to encourage others to prioritize personal and professional development
  • Complies with all applicable laws/regulations of each country in which we do business
  • Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
  • Medical Degree
  • Board Certification or Eligibility in Oncology is preferred; will consider candidates with Oncology Clinical Development experience in lieu of Board Certification
  • Clinical trial experience in an academic or industry setting; demonstrated experience and involvement in clinical trial design or execution
  • Clinical trial experience in the setting of pharmaceutical industry with demonstrated experience and involvement in clinical trial design or execution is a plus
  • Clinical experience and academic track record in solid tumors or hematologic malignancies is preferred
  • Must be able to demonstrate the ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
  • Innovative and inquisitive with a hands-on, practical approach to achieving deliverables
  • Must be a self-starter, self-motivated and must also be effective in influencing others
  • Must be able to provide guidance to Medical Monitors/ Clinical Scientists
  • Experience in writing trial synopsis, protocols, IB and study reports; Proficient with MS Office programs (PowerPoint, Excel & Word)
6

Director, Clinical Research Resume Examples & Samples

  • Directing and implementing clinical research plans and programs according to established design principles
  • Directing the integration of the CDP and DDP
  • Leading the development of the Clinical Protocols to meet CDP objectives
  • Serving as a Study Director and driving the execution of the study from protocol concept to final report including interpretation of clinical data
  • Serving as the Medical Monitor and Study Director for a study or clinical program to review and monitor study safety data
  • Implementing strategies to identify, monitor and resolve clinical program/trial issues
  • Serving as SME to provide direction to all project team functions, organizing Advisory Board meetings (e.g.) agenda setting, and identifying and liaising with KOLs regarding program strategy and scientific advice
  • Interpreting study data and developing the integrated summaries of safety and efficacy
  • Contributing clinical expertise and content to regulatory documents (e.g., briefing books, NDAs, etc
  • May represent Clinical in discussions with Health Authorities
  • 3 - 5 years of clinical research in a pharmaceutical environment; will consider candidates with prior early or later phase experience
  • Study-specific experience in the areas of liver disease and blood disorders including Thrombocytopenia are highly preferred
  • In-depth knowledge of drug development principles and clinical trial execution
  • Experience conducting global clinical trials and basic knowledge of regulatory requirements is required
  • Prior experience communicating with and presenting to Regulatory Authorities on study/program design strategy and analysis of results as they relate to filings and clinical trials is preferred
  • Prior partnership experience in drug development is highly desirable
  • The ability to lead the complexities associated with co-development efforts and work cross functionally with a collaborative style that builds alliances and emphasizes Eisai Core Values (integrity, respect, professionalism, quality and teamwork) in a fast paced environment
  • Strong team leadership and problem solving skills
  • The ideal candidate is persuasive, effective and flexible in personal interactions at all levels. with strong oral and written communication skills
7

Director, Clinical Research Resume Examples & Samples

  • Provide medical/clinical research expertise
  • Lead and design protocols
  • Evaluate safety and efficacy data
  • Analyze and summarize data for presentation to senior management and regulatory agencies
  • Provide assistance and support in managing relationships with regulatory affairs, biometrics and other non-clinical departments within Gilead
  • Provide strategic guidance and designs on non-regulatory clinical trial plans
8

Director / Senior Director, Clinical Research Resume Examples & Samples

  • Lead the creation of clinical strategies and development plans for assigned programs across development phases, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  • Be the recognized clinical expert for these development program/s both within and external to Ironwood
  • Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members, including external partners, to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
  • Assist in the preparation of clinical protocols and FDA/EMA documents (eg., INDs, annual reports, meeting requests, briefing books, and NDAs) and other relevant clinical documents
  • Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials
  • Provide clinical, scientific and development expertise to business development initiatives
  • An MD or DO degree
  • Medical expertise in internal medicine
  • A minimum of six years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3 and post-approval; for Director, a minimum of three of relevant industry experience
  • Possesses thorough understanding of strategic and operational aspects of clinical research and product development
  • Strong general knowledge of regulatory requirements such as apply to clinical drug development, with significant experience interacting directly with Health Authorities
  • Translational medicine expertise a significant plus (not required)
  • Persuasive, effective and flexible in interpersonal interactions at all levels, with strong oral and written communication capabilities
  • Strong project management and problem-solving skills
  • Specialty training and board certification, or expertise in rheumatology or nephrology would be ideal, but is not required
  • Displays sense of urgency, and a willingness to be a “player/coach” able to roll up sleeves to get the work done when necessary
9

Senior Director, Clinical Research Resume Examples & Samples

  • Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
  • Provide medical input into the design of clinical trials for these development programs
  • Serve as a medical monitor for clinical studies (provide medical oversight of the study; answer questions about eligibility; review safety and adverse event information), working closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget
  • Establish strong Scientific Advisory Groups of external thought leaders to support the development of compelling clinical development strategies and help optimize program plans and protocols
  • Collaborate with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
  • Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs
  • Provide clinical, scientific and development expertise to business development initiatives as needed
10

Director, Clinical Research Oncology Resume Examples & Samples

  • Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of Merck drugs
  • Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility
  • Must have experience in industry or senior faculty in academia
  • A proven track record in clinical medicine and background in biomedical research is essential
11

Director, Clinical Research, Oncology Resume Examples & Samples

  • Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies
  • Identification of scientifically and operationally strong investigators who can assist in the development of Merck's investigational and marketed drugs
  • Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of Merck drugs; and
  • Strong interpersonal skills, as well as the ability to function in a team environment
12

Director, Clinical Research Resume Examples & Samples

  • Manages the US Clinical Research staff in planning, conducting, and reporting clinical studies
  • Ensures that studies are conducted in compliance with applicable requirements, including department Standard Operating Procedures (SOPs), corporate policies, and regulatory requirements and guidelines (e.g., Good Clinical Practice and Good Laboratory Practice)
  • In cooperation with the other site Directors and the Head of Global Clinical Research, participates and contributes to the establishment of policies and SOPs within Global Clinical Research
  • Ensures co-operation of this department with other MAH departments
  • Monitors the activities and budgets on projects being conducted in the US Clinical Research group. Identifies when resource, time, and/or budget constraints occur and works with the US Clinical Research Team to identify solutions
  • When applicable, directly lead clinical research studies
  • Support the Project Managers in providing resources to conduct clinical studies and to participate in project team meetings
  • Provide technical and scientific support to Regulatory Affairs for existing products and products in the registration phase
  • Provide technical support to global, regional or local Marketing particularly in the launch phase of new products / indications
  • Lead the implementation of new processes or technologies in the US
  • Prepare scientific publications (article, posters or oral communications in congresses) of study results when requested
  • Maintain scientific know-how in the relevant areas in reviewing relevant scientific literature and in attending scientific and veterinary conferences
  • Guide, motivate and develop staff in the US
  • Make personnel decisions in agreement with the Head, Global Clinical Research
  • Ensure efficient organization structures and operation procedures in the area of delegation
  • Minimum 10 years of experience in clinical research or equivalent
  • A strong ability in scientific writing
  • Computer literate (Word, Excel etc.)
13

Associate Director, Clinical Research Resume Examples & Samples

  • Assist Senior Director, Clinical on developing of clinical program for projects
  • Develop and review of clinical protocols, review of scientific literature, work with physicians and external consultants to develop clinical design and project strategy
  • Review and analyze clinical trial data, prepare scientific conclusion for study results
  • Lead all necessary activities including setting up, monitoring and reporting of bio studies
  • Prepare clinical documents for IND/NDA/ANDA submissions
  • Select CROs, negotiate contracts, and maintain budgets and timelines
  • Manage CRO’s and other vendors; monitoring and audit activities to ensure studies compliance with GCP/ICH guidelines
  • Support regulatory department in response to FDA deficiency letters
  • Develop study specific training documents and investigator’s brochures
  • Conduct monitoring and co-monitoring activities
  • Participate in the development of implementation of clinical trial documents
  • Support Regulatory department in response to FDA deficiency letters
  • Maintain current knowledge of relevant regulations, including proposed and final rules
  • Interface with various departments including R&D, Regulatory Affairs, Pharmacovigilance, Marketing and Sales
  • Assist in developing clinical plans and requirements for new products
  • M.Sc. in pharmacy or life sciences or higher degree
  • Knowledge of Clinical Development Process
  • 7+ years of experience in the pharmaceutical industry
  • Strong partnering and collaboration skills
14

Director, Clinical Research Resume Examples & Samples

  • Directing and implementing clinical research plans (CDP) and programs according to established design principles
  • Directing the integration of the CDP and drug development plans - Leading the development of clinical protocols to meet CDP objectives
  • Serving as a Study Director and driving the execution of the study from protocol concept to final report, including interpretation of clinical data
  • Serving as the Medical Monitor for the overall clinical program to review and monitor study safety data
  • Serving as subject matter expert to provide direction to all project team functions, organizing Advisory Board Meetings (e.g.) agenda setting, and identifying and liaising with key opinion leaders regarding program strategy and scientific advice
  • Contributing clinical expertise and content to regulatory documents (e.g., briefing books, NDAs, etc.)
  • MD required with Board Certification in Psychiatry, Neurology or Sleep Medicine preferred
  • 3 - 5 years of clinical research in Neuroscience within a pharmaceutical environment
  • Study-specific experience in the areas of Sleep Disorders and/or Alzheimer's Disease is desirable but not required
  • Experience conducting clinical trials and basic knowledge of regulatory requirements is required
  • The ability to manage the complexities associated with co-development efforts and work cross functionally with a collaborative style that builds alliances and emphasizes Eisai Core Values (integrity, respect, professionalism, quality and teamwork) in a fast paced environment
  • Occasional travel to Investigator Meetings; up to 20% travel
15

Director, Clinical Research Resume Examples & Samples

  • Serving as the Medical Monitor, depending on qualifications, for the overall clinical program to review and monitor study safety data
  • MD required
  • 3-5 years of experience depending upon credentials, in pharmaceutical clinical research or clinical scienctific background, preferably with experience in neuroscience and especially dementia (e.g., Alzheimer’s disease)
  • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation
  • Knowledge of GCP and local regulatory requirements
  • Knowledge of medical, scientific and clinical research techniques in the neurology/psychiatry therapeutic area
  • Knowledge of the role of biomarkers and neuroimaging in evaluating pharmacodynamic effects and proof-of-pharmacology
16

Associate Director, Clinical Research Resume Examples & Samples

  • The CRM is the country point of contact (POC) for assigned protocols and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles
  • The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed
  • The CRM is responsible for clinical trial education to sites
  • The ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical. The position requires skillful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing
  • Strong communication, diplomatic and empathic skills
  • Strong organizational skills with demonstrated success required
  • Negotiation skills with both internal and external groups
  • Experience with managing clinical trials within a country from site selection to site close out
  • Experience working in a matrix environment
  • Experience in Infectious Disease studies
17

Senior Director, Clinical Research Operations Resume Examples & Samples

  • Ensure that all clinical research activities are in compliance with appropriate regulations, (including FDA, CFR, IDE guidelines, HIPAA, Conflict of Interest and Institutional policies)
  • Efficient management of resources to ensure fast patient recruitment, trial plan optimization, and execution of trials, taking advantage of existing institutional infrastructure where appropriate
  • Provide assistance, training and supervision for regulatory staff, research coordinators and research nurses
  • In conjunction with the UAHS Research Administration Office, oversee the centralized regulatory support team and coordinate submissions to the Human Subject Protection Program (IRB), including completion of regulatory paperwork as needed amendments, revisions, INDs, IDEs, Medicare Intermediary approvals, 1572s
  • Oversee the Department of Medicine clinical research /clinical trials operations and performance
  • Work directly with faculty to ensure that they have support in the design, implementation and execution of their research protocols
  • Provide other appropriate assistance to ensure quality and timely completion/submission of case report forms and other study management reports
  • Develop and implement Standard Operating Procedures for clinical research operations
  • Demonstrated skills in leadership and team-building
  • Ability to accommodate and respond to shifting priorities and multiple, demanding projects, in a manner that is effective and efficient
  • An established record of personal and professional ethics, character and integrity
  • BA or BS in Business, Finance or related field of study required, and eight (8) years of experience in a research/clinical research compliance
  • Certifications in Phlebotomy, IATA Shipping, Blood Borne Pathogens and Good Clinical Practice
  • Experience working within a university research or academic medical center compliance office, or healthcare organization with significant university research contacts
  • Expert knowledge of key compliance regulations, including those related to clinical research and use of human subjects
  • Successful, proven experience in administrative leadership within academia, or in a comparable position
18

Director, Clinical Research ID / HIV Resume Examples & Samples

  • Responsible for clinical research protocol development and medical/scientific oversight of clinical trials (Phases 2-4) involving experimental or marketed drugs in the infectious disease clinical research group
  • Participates in all phases of clinical development process for Merck Research Laboratories sponsored studies including study design, medical monitoring and medical/scientific interpretation of study analyses for both efficacy and safety non-study safety reports and scientific and regulatory document authoring
  • Apply an in-depth understanding of the disease under study and provide input to the development and implementation of short and long-term objectives of the infectious disease clinical research group
  • Provide internal scientific leadership for cross functional areas supporting clinical development and external leadership through interaction with study investigators
  • Infectious disease/HIV background and/or experience in clinical trials of infectious disease drugs (preferably HIV)
  • Demonstrated ability to work as part of a high performing team
19

Senior Director, Clinical Research Resume Examples & Samples

  • MD required, with Board Certification
  • 10+ years of experience in pharmaceutical clinical development, with experience in Neurology and Phase II-III, global, multicenter studies
  • A thorough understanding of clinical research methodology including study design, protocol writing and study report preparation
  • Direct measurable experience in the Medical Affairs discipline, interacting with KOLs, research centers, etc
  • Experience/active participation in LCM and commercial development activities
  • Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industrial experience
  • Knowledge of medical, scientific and clinical research techniques in the neurology area
  • Prior experience participating in the selection of new compounds for clinical development and IND filing in Neuroscience through technical evaluation of licensing and/or partnership opportunities
  • Experience developing and implementing paradigms for novel data analysis
20

Associate Director Clinical Research Informatics Resume Examples & Samples

  • Oversees data management design and implementation (including data collection, enrichment, tracking, intake and export), ensuring adherence to milestones and deliverables
  • Leads on defining the strategic data collection, storage, management, tracking, sharing and integration requirements and plans for the Study; data could be subject information or research data
  • Leads on executing projects that support the development of data collection, storage, management, tracking, sharing and integration systems (key projects to support will include, systems to support subject tracking and outreach management, in-person assessments tracking and data needs and systems, remote data collection data needs and systems, and biospecimen data collection needs and systems)
  • Acts as key liaison between research team and data platform and tools team to ensure all study team requirements are appropriately translated and executed
  • Partners with Study’s research staff to understand data management and systems needs and translates requirements to appropriate parties (i.e., vendors, consultants, internal resources)
  • Oversees the development and build of new approaches for data intake and data export and sharing with external parties (e.g., co-investigators, study subjects, etc)
  • Works closely with co-investigators and the appropriate parties in their organizations to understand and define data needs, requirements and systems for sharing and integration with FPHS systems
  • Serves as key liaison with informatics and data teams from across the university, partnering hospitals and other institutions to define and execute projects
  • Develops requirements for and maintains and refines processes and systems to support designated program and project work
  • Oversees and manages relationships with vendors and consultants as required
  • Supports the development of IRB research protocols as necessary
  • Leads weekly meeting of research team and data platform and tools team
  • Defines data management and systems staffing requirements as the program grows and shifts
  • Hires and supervises data management and systems staff
  • Represents project to the faculty and staff of Harvard and other external stakeholders as needed (e.g., at internal meetings, board meetings, conferences)
  • Other related duties as assigned
  • Bachelors degree in bioinformatics, medical science, management or health care related field
  • Eight or more years of related experience preferably in an academic, health care, or other complex environment or an equivalent of education plus relevant experience is required
  • Five or more years of experience managing clinical research
  • Five or more years human subjects study management
  • Knowledge of, interest in and experience with long-term research studies, clinical trials and/or sports medicine
  • Proven program management skills including an ability to manage multiple projects and coordinate staff
  • Proven data management skills and experience
  • This position requires specific technical skills in database systems and database design
  • Familiarity with SQL, SAS, R and/or similar tools
  • Proficiency with relational database systems
  • Solid understanding of research data system implementation best practices and appropriate use of design patterns
  • Excellent organizational, interpersonal and communication skills are essential
  • Excellent computer skills, including knowledge of Microsoft Office and Outlook
  • Ability to work across teams and with a variety of projects and constituencies
  • Previous experience in academia or health care will be highly valued
  • The successful candidate will have a proven track record of executing and delivering on projects in a complex and shifting environment with multiple and at times conflicting interests
  • The successful candidate must have the ability to exercise good judgment on a range of issues, many of which are confidential in nature, and to manage complex projects through to completion
21

Associate Director Clinical Research Resume Examples & Samples

  • A minimum of a Bachelor's degree is required
  • Advanced degree (MD, MS, RN, RD, PhD or PharmD) is preferred
  • A minimum of at least 3 years of clinical research and development experience within the Pharmaceutical, Medical Device OR CRO industry or experience as clinical research coordinator in non-industry setting is required
  • Independent decision-making and analytical skills are required
  • Travel up to 20% of time both domestic and international is required
22

Associate Director Clinical Research Resume Examples & Samples

  • You possess a Bachelor’s or higher degree, preferably in Life Sciences (e.g., Biology, Chemistry, Nursing, and Pharmacy)
  • You have 8 or more year’s clinical trial experience in the pharmaceutical/ medical device industry and or CRO
  • You are able to lead all aspects of execution of a clinical trial and you demonstrate expertise in vendor management
  • You excel in organizing and motivating global or regional teams in a virtual environment
  • You are a coach and a mentor
  • Able to travel up to 20% of the time, (as defined by business need)
  • Experience executing Phase II & III clinical trials
  • Relevant experience in associated Therapeutic Area
23

Site Director, Clinical Research Resume Examples & Samples

  • B.A. or B.S. required, advanced degree preferred; minimum of 5+ years progressive experience in managing a Phase I clinical research facility
  • At least 10+ years prior experience in Phase I clinical research preferred
  • Understanding of Clinical Research Requirements: Familiar with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International
  • Conference on Harmonization (ICH) guidelines
  • Communication: Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff. Skilled in persuading potential sponsors to place research with the site
  • Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment
  • Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy
  • Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change
  • Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations
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Director, Clinical Research Finance Resume Examples & Samples

  • 5) Lead and direct the OCR Finance Manager and staff to establish procedures for effective monitoring of patient enrollment, cash position (A/R) and overall appropriate study expenditures through to close out and residual transfer if applicable
  • 6) Oversee the financial health of clinical trial activity within Penn Medicine. Report to Senior Leadership with annual plan including multi-year forecasts, including overall clinical trial activities, level of faculty engagement, ranges of sponsorship, etc
  • 7) Responsible for execution and maintenance of research financial and compliance training for Clinical Trials administration throughout Penn Medicine
  • 8) Ensure financial compliance with institutional, federal and non-federal policy, rules and regulations
  • 9) Provide leadership and direction for the financial training and professional development to Departmental BAs and OCR Finance Unit
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Director, Clinical Research, Vaccines Resume Examples & Samples

  • Board certified or eligible in a vaccine-related clinical field such as Internal Medicine, Obstetrics Gynecology, Family Medicine,or Pediatrics
  • Clinical Research experience with evidence of strong scientific productivity such as authorship on published manuscripts
  • Excellent communication and writing skills
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Director, Clinical Research Operations Resume Examples & Samples

  • Bachelor's degree required. Preferably in clinical healthcare field (BSN, RPh) or healthcare Administration, business, science or related field
  • Master's degree or higher preferred (PhD, MBA, Pharm.D., MSN)
  • Ten (10) years of current clinical research operations management experience, preferable in a hospital setting may substitute for master's education
  • 5-8 years of healthcare management experience in a multi-specialty research and/or inpatient healthcare provider environment
  • 5 years of progressively responsible management experience
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Director Clinical Research Resume Examples & Samples

  • Oversight of productivity and quality standards for the Infusion Center
  • Oversight for nursing and physician research studies
  • Facilitate Care Assure program at the facility level
  • Manage special projects with an emphasis on research, quality and patient safety approach
  • Promote harmony and builds rapport with physicians, patients, families, peers and customers
  • Serve as a role model to promote excellence and safety in accordance with Evidence Based Practice
  • Work closely with nursing leadership to monitor adequate compliance with procedures related to regulatory agency standards, national patient safety goals and sentinel alerts to promote a safe environment of care, reports failures and initiates corrective action when appropriate
  • Current FL RN license
  • BSN required, MSN strongly preferred
  • 5+ years nursing experience in the acute hospital environment
  • Minimum 2 years in a leadership/management capacity
  • Minimum 1-2 years teaching/instruction/adult clinical learning experience in a similarly sized health care system or acute care facility
  • Clinical Research experience preferred
  • Event Coordination and Poster preparation experience
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Director Clinical Research Operations Resume Examples & Samples

  • Provides direct leadership and management for PHC research operations team members
  • Recruits, hires, and develops professional staff as needed to support an effective research administrative infrastructure
  • Creates effective training programs, policies, and processes to ensure work standardization and research team and key stakeholder understanding of ethical and regulatory guidelines
  • Continuously evaluates research program compliance, quality, and effectiveness, identifies, and develops opportunities for improvement that provide greater value for stakeholders
  • Leads process improvement and organizational change initiatives toward program optimization
  • Partners and collaborates with the PHC Compliance office to evaluate and address research compliance issues and risks
  • Reviews existing and, as necessary, develops new policies and procedures to ensure compliance with all applicable institutional, local and federal regulations, and PHC policies
  • Encourages expanded participation from existing physician investigators through action oriented and expert support and helps to inspire and support new investigators in the sponsored research program
  • Organizes and structures PHC research administrative services to expand the capacity of the research program with a focus on increasing and diversifying sources of revenue and financial support
  • Directs an effective system of marketing and communication across PHC, the research community, and key stakeholders, to build and promote a positive image of PHC sponsored research
  • Oversees the identification, evaluation, development, and implementation of technology to support sponsored research
  • Coordinates with research financial administration and accounting and is responsible for ensuring the financial viability of the overall research program
  • Monitors and reports on the performance, compliance, and general operation of the PHC sponsored research program
  • Develops annual research operation budgets and strategic initiatives aligning with PHC’s strategic plan
  • Supports and executes on the strategic focus of key research service lines working with their respective administrative and physician leads
  • Effectively collaborates and coordinates with key ancillary clinical and non-clinical services including revenue cycle, supply chain, laboratory services, imaging services, and others
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Director Clinical Research Resume Examples & Samples

  • A minimum of at least 5 years of clinical research and development experience within the Pharmaceutical, Medical Device OR CRO industry or experience as clinical research coordinator in non-industry setting is required
  • Clinical research operational knowledge, strong project planning/management and excellent communication skills is required
  • Ability to operate with limited day to day supervision is required
  • Experience in Neuroscience Therapeutic Area is desired
  • Successful work experience in a matrix team environment with cross functional teams is required
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Director, Clinical Research Resume Examples & Samples

  • Serves as Study Director for a study or clinical program; including review of study safety data and implementing strategies to identify, monitor and resolve clinical program/ trial issues. Leading the Clinical Subteam
  • Serving as a SME to provide direction to all project team functions, Organizing Advisory Board meetings (e.g., agenda setting), and identifying and liaising with KOLs regarding program strategy and scientific advice
  • Ph.D required, ideally in Neurology or Psychiatry
  • A minimum of 7-10 years in pharmaceutical clinical development with experience directing Neurology Phase II-III global multicenter studies
  • Knowledge of scientific and clinical research techniques in the neurology area
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Assistant Director, Clinical Research Resume Examples & Samples

  • Prior Oncology clinical trials experience and working knowledge of NCTN cooperative group system
  • Experience with monitoring and/or auditing
  • Research certification (ACRP/SOCRA)
  • Experience with Excel, PowerPoint and Word
  • Must work independently, interact professionally, interpret complex policies and procedures and possess effective technical writing and organizational skills
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Director, Clinical Research Resume Examples & Samples

  • Must have experience in industry or academia
  • Demonstrated record of scientific scholarship and achievement
  • Prior specific experience in clinical research and prior publication is desirable but not necessary
  • Strong interpersonal skills, as well as the ability to function in a team environment are essential
33

Director, Clinical Research Resume Examples & Samples

  • Must have a minimum of 2 years of experience in industry
  • Training and expertise in molecular imaging and biomarkers in cancer developmental therapeutics
  • Prior specific experience in clinical research and prior publication
34

Director, Clinical Research Dermatology Resume Examples & Samples

  • Participate in setting the drug development strategy for the Dermatology clinical program
  • Play a significant leadership role, as well as provide “hands on” work and work in collaboration with relevant team members and peers to ensure the highest level of execution for Dermatology clinical development programs
  • Clinical Study Design and Execution
  • Experience on teams with early and late stage development products (Phase 3 to regulatory submission)
  • Experience leading Medical Advisory Boards
  • Strong project management skills, business savvy and business development experience is desirable
  • Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others
  • Ability to produce highest quality timely clinical development work product/document with limited direction under tight time constraints
  • Hands-on performer, ensuring strong execution of clinical trials and other drug development activities
  • Flexibility and adaptability, able to thrive in small biotechnology company environment
  • A superior work ethic and a strong personal desire for success. He or she must also possess a strong sense of personal and professional ethics
  • A good balance of confidence and humility
  • Must be passionate about developing treatments for rare/orphan diseases
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Senior Director, Clinical Research Services Resume Examples & Samples

  • Demonstrated expertise in a variety of fields related to the conduct and management of clinical oncology, HIV/AIDS and Diabetes research
  • Development and effective implementation of performance metrics which drive cost efficiency and optimal results
  • Reliance on experience, expertise and judgment to define and accomplish goals
  • Facilitated communication among leaders and stakeholders at all organizational levels
  • Lead and direct the work of others to oversee the conduct innovative clinical trials and advance the standard of care towards best practices in clinical research
  • Bachelor’s degree, Master’s degree preferred
  • Seven years of progressive clinical trial administrative management experience in a large, complex organization
  • Sound financial background in an academic or non-profit setting
  • Experience at a non-profit and/or higher education medical center is required with knowledge of oncology clinical trials
  • Experience with Epic EHR system and OnCore CRMS
  • Strong experience financially managing a large portfolio of industry-sponsored and non-industry sponsored clinical trials
  • Strong knowledge of clinical research, including Medicare coverage analyses and clinical trials budgeting and federal guidelines/regulations pertaining to clinical research
  • Demonstrated knowledge of Electronic Health Records System and Clinical Research Management System
  • Must be detail-oriented with strong problem-solving skills
  • Must have the ability to work closely and effectively with a diverse group of administrators; strong interpersonal and leadership skills; proven ability to effect and influence change through a collaborative and inclusive style
  • Expresses commitment to City of Hope’s mission, personally identifies with its vision and takes pride in shared success
  • Exhibits flexibility while influencing others to improve processes and implement changes
  • Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required