Director of Clinical Operations
Join the HJF Team!
HJF is seeking a Director of Clinical Operations to support the Center for Neuroscience and Regenerative Medicine (CNRM) located in Bethesda, MD. This position will start as telework and will transition to the office at a later date. HJF provides scientific, technical and programmatic support services to CNRM.
Director of Clinical Operations to support the Center for Neuroscience and Regenerative Medicine (CNRM) in Bethesda, Maryland. The Director of Clinical Operations will be responsible for leading the activities of the Clinical Trials Unit (CTU) in the preparation for the implementation and execution of CNRM clinical trials in accordance with the Program research development plan and mission. This position reports to the Director and supervises a team of clinical trial support staff.
- Lead in house Clinical Operations, to include development and review of clinical operations processes, systems and initiatives. (20%)
- Work with Program Leadership to develop and drive study timelines and study implementation and operational plans. Participates in resource prioritization across teams to ensure clinical operations strategic goals and milestones are achieved. (20%)
- Interface with the CNRM Program personnel when needed regarding follow-up of status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities). (15%)
- Manage CTU staff, to include providing professional development, and performance management. (15%)
- Provide strategic input into the development of clinical trial protocols ensuring studies deliver according to principles of Good Clinical Practice (GCP), and collection and analysis of clinical trials data. (10%)
- Proactively develops and executes clinical trial portfolio-specific project and risk management plans as needed. (10%)
- Review and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure. (10%)
- May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.
Required Knowledge, Skills and Abilities: Demonstrated effective planning and project management skills, proven track record of conducting, managing clinical trials, excellent written and verbal communication skills, strong management and collaborative skills with demonstrated ability to effectively mentor study managers and clinical trial staff, ability to effectively manage interactions with internal and external collaborators to achieve program goals. Experience with Clinical Trials Management System a plus.
Minimum Education/Experience: Master’s degree plus 6-8 years of experience or Bachelor's degree and 10+ years of experience
Work Environment: Set in an office environment.
Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC). U.S. Citizenship required.
Travel: Currently most of this program is working remote but once we resume normal operations, this position will have up to 25% travel.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.