Director, Clinical Research Job Description

Director, Clinical Research Job Description

4.8
182 votes for Director, Clinical Research
Director, clinical research provides scientific and clinical guidance to Research, Biology, Virology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.

Director, Clinical Research Duties & Responsibilities

To write an effective director, clinical research job description, begin by listing detailed duties, responsibilities and expectations. We have included director, clinical research job description templates that you can modify and use.

Sample responsibilities for this position include:

Serve as a medical monitor for clinical studies (provide medical oversight of the study
Collaborates with physicians in other medical specialties
Support the development, execution and communication of the global scientific/medical evidence plan
Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
Provides safety surveillance guidance and acts as a medical monitor for clinical trials
Guiding and supervising CR and MI tasks across all projects
Developing, preparing and managing the global CR and MI budget, with support and input from Head of MI and Clinical Research Managers, including the GMRA modality working group member from CR
Determining resource needs and outsourcing requirements for CR and MI, including the assignment of CRM to modality working groups
Managing and tracking Key Performance Indicators (KPIs) for CR and MI activities
Reporting results of performance of CR and MI via KPIs and presenting the results to the Sr

Director, Clinical Research Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Director, Clinical Research

List any licenses or certifications required by the position: FEMA, ACRP, OCN, PMP, CPSM, ASCP, CCRP, CRC, ACP

Education for Director, Clinical Research

Typically a job would require a certain level of education.

Employers hiring for the director, clinical research job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Education, Nursing, Business, Medicine, Management, Health, Healthcare, Oncology, Science

Skills for Director, Clinical Research

Desired skills for director, clinical research include:

Medical
Biology
GCP and local regulatory requirements
Key areas of early drug development
Toxicology and early clinical development
Translational and clinical cancer research and its application to cancer drug development is of paramount importance
Currently available clinical technologies and assessment tools
Drug mechanisms of action
IND/NDA process acquired through direct industrial experience
Scientific and clinical research techniques in assigned therapeutic area

Desired experience for director, clinical research includes:

Managing vendor selection in collaboration with Management Services (MS) and approving final recommendations for vendor selection for CR and MI activities
Approving the assignment of tasks to be accomplished by outside vendors and/or consultants
Providing projections for enrollment for clinical trials and IIS for yearly insurance policy coverage
Defining and approving CR and MI Standard Operating Procedures (SOPs)
Conducting meetings with direct reports to disseminate information, optimize processes, and improve communication
Defining business objectives for CR and MI

Director, Clinical Research Examples

1

Director, Clinical Research Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of director, clinical research. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for director, clinical research
  • Contributes to the preparation of research manuscripts for publication in the area of TBI
  • Collaborates with Program Manager and monitors contract program activities
  • Ensures effective communication and knowledge sharing with DVBIC research colleagues
  • Attends and presents at conferences
  • Establishes and maintains appropriate staff to ensure that clinical research projects (and patient care
  • Serves as a liaison between DVBIC nationally
  • Responsible for the completion of individual workload accountability in accordance with research program
  • Abides by all applicable regulations with regard to Utilization Review and Quality Improvement directives including
  • Assists other contract service providers
  • Participates
Qualifications for director, clinical research
  • Solid Clinical Trials background
  • Experience and/or skills in of these research, business, software, web technology, or related areas is desired but not required
  • High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards
  • The successful candidate must be equally comfortable among the team to which he/she is assigned and in the global environment in which the company operates
  • The Director of Clinical Research, Oncology, will be the key physician contact for sites and investigators during site start-up and study execution
  • The Director will act as a liaison between the company and clinical investigators
2

Director, Clinical Research Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of director, clinical research. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for director, clinical research
  • Participate and provide clinical input into safety and regulatory interactions
  • Expertise in using the scientific methods to test hypotheses, including statistical design, analysis, and interpretation of clinical study results
  • Knowledge of the pharmaceutical industry/regulatory drug development process for pediatric drug development
  • Collaborate closely with Global Oncology Program Teams on design, implementation and reporting of pediatric elements of a Clinical Development Plan to support decision milestones and regulatory approval
  • Interprets study data and develops integrated summaries for safety and efficacy
  • Contributing clinical expertise and content to regulatory documents (e.g., briefing books, NDAs
  • The successful candidate will have oversight for ongoing and planned product trials within the cardiovascular therapeutic area
  • The Clinical Research MD will report to a more senior member of the cardiovascular clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
  • 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
  • Supervise the activities of Clinical Scientists in the execution of clinical studies
Qualifications for director, clinical research
  • He/She will be providing leadership for Phase 3 studies
  • He/She evaluates scientific information and new ideas to assist in identifying new research opportunities
  • To meet requirements, a Ph.D
  • Travel required may be up to 25 % annually (international, domestic)
  • Experience both with Stanford and industry practices
  • Minimum 3-10 years of training or experience working with patients with traumatic brain injury required (in areas of research
3

Director, Clinical Research Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, clinical research. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, clinical research
  • Participate in ongoing in vitro, in vivo and clinical data review and interpretation of data analyses of clinical trial results
  • Responsible for review and analysis of clinical data including safety monitoring in collaboration with Product Safety
  • Review serious adverse event (SAE) reports from ongoing clinical studies and spontaneous reports
  • Preview listings, lab reports, and subject profiles as defined within the Safety Monitoring Plan
  • Additional tasks may involve attendance and participation at Investigator Meetings, preparation of subject narratives, review of study reports and other documents, preparation and/or review of periodic and interim safety reports
  • Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations
  • Development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept
  • Identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation, and executing clinical studies that can be bridged into full development
  • Key member of early development teams, providing leadership in designing and executing early clinical development strategy
  • Safe and timely execution of Phase I studies
Qualifications for director, clinical research
  • Prior experience within the DoD/VA systems of care and providing clinical and/or research services to individuals
  • Strong knowledge in human research activities
  • Experience with and/or knowledge of current TBI research is highly desired
  • Ability to function independently with a high degree of professionalism and clinical judgment required
  • Experience with grant application processes and implementation is highly desirable
  • Ability to facilitate and present information to small and large groups the flexibility to re-prioritize quickly required
4

Director, Clinical Research Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of director, clinical research. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for director, clinical research
  • Across a range of sites
  • Direct Partner Sites staff assuring project deliverables are achieved for each role within span of control
  • Managers within area of accountability to develop staff along career progression goals and strategic departmental and
  • Corporate priorities
  • Act as Relationship Manager for certain Partner Sites as required and ensure Partner Sites are meeting the performance
  • Metrics required by the business
  • Implement agreed strategic actions for Partner Sites across designated region/country
  • Initiatives within assigned unit of accountability including development of measures for success
  • Provide leadership and approval for the resourcing process and outcomes, hiring targets and processes and on-boarding
  • And training standards
Qualifications for director, clinical research
  • He/She will develop, in concert with senior clinical staff, credible relationships with opinion leaders
  • Ability to work as part of a multidisciplinary health care team is required
  • Knowledge and experience with military health system
  • Must adhere to legal
  • Must have a high level of competence in research methods
  • Demonstrated ability to drive critical initiatives involving multiple business functions
5

Director, Clinical Research Job Description

Job Description Example
Our company is looking to fill the role of director, clinical research. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for director, clinical research
  • Efficiencies, project outcomes and quality metrics for operation processes and roles
  • Provide leadership to ensure Partner Sites meet or exceed customer expectations
  • Execution of Partner Sites processes
  • Effectively communicate and describe all Partner Sites service to internal and external customers
  • Strategic goals
  • Ensure Partner Sites are meeting the performance metrics required by the business
  • Ensure internal processes are aligned with other stakeholder Departments to optimize use of Partner Sites
  • Contribute to the evaluation of the suitability of protocols for a Partner site recruitment solution, supporting Business
  • Development and Proposals as appropriate
  • Oversee or perform Partner Assessment Visits
Qualifications for director, clinical research
  • Travel, including both domestic and international, will be up to 25-50% of the job requirement
  • A minimum of three years within the industry or in a similar position would highly preferred
  • Subspecialty training in pediatric oncology and/or hematology desirable
  • Writing of clinical study protocols, monitoring of clinical trials
  • Clinical trial experience in an academic or industry setting
  • Experience in writing trial synopsis, protocols, IB and study reports

Related Job Descriptions

Resume Builder

Create a Resume in Minutes with Professional Resume Templates