Manager, Clinical Operations

About Meridian

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.

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.

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.

• 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…