Director, Clinical Research Job Description
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:
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:
Desired experience for director, clinical research includes:
Director, Clinical Research Examples
Director, Clinical Research Job Description
- 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
- 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
Director, Clinical Research Job Description
- 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
- 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
Director, Clinical Research Job Description
- 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
- 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
Director, Clinical Research Job Description
- 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
- 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
Director, Clinical Research Job Description
- 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
- 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