Job Summary
The Manager, Clinical Operations is a seasoned professional with wide-ranging experience and a thorough understanding of clinical study management, biospecimen acquisition, FDA and ICH regulations and Good Clinical Practices (GCP). The candidate must be self-motivated, able to work and lead in a remote team environment and be able to establish strong, positive relationships with both internal departments, external clinical study sites and biospecimen vendors.
The successful candidate contributes to the development of Clinical Affairs processes and procedures at the project and company levels pertaining to Clinical Operations involvement in our clinical studies. The Manager, Clinical Operations will provide leadership and career development, mentoring and training for CRA, biorepository and clinical trial logistics staff as well as is responsible for Clinical Operations staff resourcing.
Key Duties
Tasks/Duties/Responsibilities:
- Manage and facilitate the personal development of CRAs, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor and guide to junior employees. In addition, oversee the personal development of clinical trial logistics and biorepository personnel.
- Partner with the Clinical Affairs Director to create and implement the strategic vision for the Clinical Operations team to ensure the high-quality end-to-end management of clinical trials, clinical trial logistics and internal/external biospecimen acquisition.
- Lead Clinical Operations level initiatives for the development, maintenance and implementation of processes, tools, templates and plans.
- Regularly monitor the overall health of the clinical studies from the study initiation to closure including regular evaluation of key metrics (enrollment, site activation), monitoring and escalation of project risks and mitigation plans when appropriate.
- Lead and prepare the content for internal meetings with leadership, internal cross functional teams and external collaborators.
- Functions as a working manager and takes on CRA responsibilities, as needed
- Oversee CRAs during site visits (site initiation visit, interim monitoring visits and close-out visits), as needed.
- Oversee the clinical operations aspects of timely data monitoring and partner with Clinical Affairs team leaders and study sites regarding generation and reconciliation of queries to ensure business timelines are met.
- Direct the creation and collection of required study documents both internally and with the investigational study sites.
- Responsible for all aspects of the biospecimen acquisition program, including forecasting and managing resources, timelines and budgets for external and internal biospecimen acquisition.
- Implement strategies and best practices for the Clinical Operations team to build and maintain relationships with investigational study sites and vendors.
- Responsible for resource allocation for the Clinical Operations team for assigned projects.
- Other duties as assigned.
Qualifications
- B.S. in Biological/Health Sciences or related Scientific fields; master’s degree preferred
- Certificate of completion from a Clinical Research Associate program is preferred
- Minimum of 5 years of experience mentoring, managing, and leading a team
- Minimum of 5 years experience as a CRA and/or Lead CRA
- Minimum of 1-2 years experience with managing and/or working in clinical trial logistics and/or biorepository operations.
- Experience with internal sample collection is preferred.
- Basic knowledge in the areas of microbiology, immunology or molecular biology and biochemistry as related to infectious diseases.
- Thorough knowledge of FDA, ICH and GCP guidelines
- Strong knowledge and experience with TMF/eTMF, EDC systems and CTMS preferred.
- Be an initiative-taker, detail oriented, organized, and able to prioritize and balance workloads to meet strict critical deadlines along with performing under pressure in a fast- paced environment.
- Highly motivated, readily adapts to changing priorities.
- Excellent organizational skills with high attention to detail is required.
- Able to work successfully under tight timelines.
- Ability to manage, prioritize, and routinely report progress on multiple projects to cross functional teams and Clinical Management.
- Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
