Remote Clinical Operations Leader Trials & Biospecimens

Meridian Bioscience Inc.; Cincinnati (OH); On-site; USD 90,000 - 140,000; Full time

Job summary

Meridian Bioscience Inc. seeks a Manager, Clinical Operations to lead a remotely located team, overseeing clinical study management, biospecimen acquisition, FDA and ICH regulations, and GCP compliance.

You will develop Clinical Affairs processes, mentor CRA and biorepository staff, allocate resources, and ensure timelines and budgets align with project goals while coordinating with internal departments and external sites.

Qualifications

• Bachelor of Science in Biological/Health Sciences or related scientific field; 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.
• 1–2 years experience with managing and/or working in clinical trial logistics and/or biorepository operations.

Responsibilities

• Mentor CRAs and clinical trial logistics staff, fostering career development.
• Partner with Clinical Affairs Director to define strategic vision for Clinical Operations.
• Lead initiatives for processes, tools, templates and plans within Clinical Operations.
• Monitor study health from initiation to close, including enrollment and site activation.
• Oversee site visits and data monitoring coordination to meet timelines.
• Direct creation and collection of required study documents with sites.
• Manage biospecimen acquisition programs, timelines, resources and budgets.

Skills

Mentoring & leadership

Project management

Attention to detail

Prioritization

Education

B.S. in Biological/Health Sciences or related Scientific fields; master’s degree preferred

Certificate of completion from a Clinical Research Associate program

Tools

TMF/eTMF

EDC systems

CTMS

Job description

Meridian Bioscience Inc. seeks a Manager, Clinical Operations to lead a remotely located team, overseeing clinical study management, biospecimen acquisition, FDA and ICH regulations, and GCP compliance.

You will develop Clinical Affairs processes, mentor CRA and biorepository staff, allocate resources, and ensure timelines and budgets align with project goals while coordinating with internal departments and external sites.