Clinical Operations Manager

The Clinical Operations Manager is responsible for overseeing the daily operations and overall performance of the Clinical Operations team, ensuring compliance, efficiency, and high-quality execution of all clinical trials conducted at the site. This role provides leadership to the Clinical Research Coordinators (CRCs) and other operations staff, ensuring studies are conducted according to protocol, regulatory requirements, and site standards.

• Supervise Clinical Research Coordinators (CRCs), providing coaching, mentorship, performance feedback, and career development.
• Oversee and support the Assistant Clin Ops Manager, who manages Research Assistants (RAs) and Laboratory Technicians.
• Lead team meetings, set clear expectations, and ensure accountability across all Clin Ops functions.
• Foster collaboration between Clinical Operations, Recruitment, and other site departments.
• Ensure trials are conducted in compliance with ICH-GCP, FDA regulations, IRB requirements, and site SOPs.
• Monitor workload distribution and study assignments for CRCs; adjust as needed to optimize efficiency and balance priorities.
• Identify and implement process improvements to streamline operations and enhance participant and sponsor satisfaction.
• Oversee internal audits and assist with sponsor, CRO, and FDA inspections to ensure site readiness at all times.
• Develop, track, and present Clin Ops performance metrics (weekly, monthly, and annual) to site leadership.
• Monitor study timelines, enrollment progress, and data quality; proactively address barriers to success.
• Provide input on site capacity, staffing needs, and study feasibility to support business development.
• Serve as a lead coordinator on select clinical trials, ensuring protocol adherence, participant management, and data oversight.
• Contribute to the development of study-specific documents and processes (e.g., process flows, CRFs, training materials).
• Support recruitment and retention strategies by collaborating with recruitment staff and engaging directly in patient-facing activities as needed.
• Participate in site-level leadership meetings and annual strategy planning sessions.
• Provide input on study contracts, budgets, and operational considerations as requested by the executive team.
• Support hiring, onboarding, and training of new Clin Ops staff, ensuring smooth integration and adherence to site standards.

• Excellent communication, leadership, and organizational skills.
• Strong attention to detail, flexibility, and a collaborative mindset.
• Minimum of 3-5 years of experience in clinical research or equivalent.
• Minimum of 2-4 years of experience managing a team.