[Hiring] Manager, Clinical Operations @Meridian Bioscience, Inc.

Role Description

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 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 be responsible for Clinical Operations staff resourcing.

Key Duties

• 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, overseeing 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.
• 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 initiation to closure, including evaluation of key metrics (enrollment, site activation) and escalation of project risks.
• 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 clinical operations aspects of timely data monitoring and partner with Clinical Affairs team leaders and study sites regarding query generation and reconciliation.
• 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.
• 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 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 deadlines.
• Highly motivated, readily adapts to changing priorities.
• Excellent organizational skills with high attention to detail.
• 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 ensure compliance in direct reports.