Manager, Clinical Operations

About the Company

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting-edge solutions to tough problems.

About the Role

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.

Responsibilities

• Manage and facilitate the personal development of CRAs, including fostering career growth and providing relevant company-specific, ethical, and regulatory trainings. Serve as a mentor and guide to junior employees. 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 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 clinical studies from initiation to closure, including evaluation of key metrics (enrollment, site activation), monitoring, and escalation of project risks and mitigation plans.
• Lead and prepare content for internal meetings with leadership, internal cross-functional teams, and external collaborators.
• Function as a working manager and take 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 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.
• Travel: 30%
• 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 of experience as a CRA and/or Lead CRA.
• Minimum of 1-2 years of 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.
• Initiative-taker, detail-oriented, organized, and able to prioritize and balance workloads to meet strict critical deadlines while 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.