Clinical Operations Manager

Clinical Operations Manager

Prime Clinical Research
Location: On-Site
Employment Type: Full-Time
Department: Clinical Operations
Reports To: Chief Executive Officer or Principal Investigator

Prime Clinical Research is seeking an experienced Clinical Operations Manager to lead the operational delivery of clinical trials conducted at our research site. This role oversees study planning, research staff performance, patient recruitment operations, regulatory compliance, and study execution to ensure clinical trials are conducted efficiently and in accordance with sponsor requirements and Good Clinical Practice (GCP).

The Clinical Operations Manager plays a critical leadership role by translating clinical study protocols into operational plans, ensuring clinical research teams operate effectively, and maintaining inspection-ready clinical trial documentation. This position focuses on operational oversight and team leadership rather than routine patient visit coordination or data entry.

This is an excellent opportunity for an experienced clinical research professional who enjoys building high-performing research teams and delivering high-quality clinical trial operations.

Key Responsibilities

Clinical Trial Operations Leadership

• Lead the operational execution of clinical trials from study start-up through closeout
• Translate study protocols into site-level operational plans including staffing, recruitment strategies, and visit workflows
• Monitor study timelines, enrollment performance, and operational milestones
• Ensure research activities are conducted in compliance with study protocols, FDA regulations, and ICH-GCP guidelines

Operational Performance and Oversight

• Monitor key operational indicators including enrollment performance, monitoring visit follow-ups, data query timelines, and protocol deviation trends
• Implement operational improvements when study performance, documentation quality, or compliance concerns arise
• Maintain inspection-ready clinical research documentation across regulatory files, CTMS systems, and source records
• Identify operational risks and implement mitigation strategies to prevent delays or compliance issues

Team Leadership and Staff Development

• Provide leadership, coaching, and operational guidance to Study Coordinators and research staff
• Promote accountability, operational discipline, and high-quality research documentation
• Establish consistent operational rhythms including team meetings, performance check-ins, and study progress reviews
• Support onboarding and professional development of clinical research staff

Sponsor and Investigator Collaboration

• Serve as a primary operational contact for investigators, sponsors, and CRO partners
• Coordinate sponsor monitoring visits, audits, and regulatory inspections
• Provide operational reports summarizing study progress, enrollment performance, and operational risks
• Support investigators in fulfilling oversight responsibilities including timely review and approval of study documentation

Quality and Compliance

• Ensure regulatory documentation, investigator oversight records, and source documentation remain complete and inspection-ready
• Lead root-cause analysis for operational or quality issues and implement corrective and preventive actions (CAPA)
• Support regulatory compliance across all active clinical trials

Required Qualifications

• Bachelor's degree in life sciences, nursing, public health, or a related field, or equivalent clinical research experience
• Minimum 5 years of clinical research experience with responsibility for study operations or clinical trial management
• Experience managing clinical trials from study start-up through closeout
• Strong knowledge of ICH-GCP guidelines and FDA clinical research regulations
• Experience working with clinical research systems such as CTMS, EDC, or eTMF
• Demonstrated leadership or supervisory experience in a clinical research environment

Preferred Qualifications

• Clinical research certification such as CCRP, CCRA, or equivalent
• Experience supporting sponsor audits or regulatory inspections
• Experience managing multiple concurrent clinical trials
• Experience implementing patient recruitment strategies or operational improvements

Technology Experience

Experience working with clinical research technology platforms including:

• Clinical Trial Management Systems (CTMS)
• Electronic Data Capture (EDC)
• Electronic Trial Master File (eTMF)
• Electronic Source (eSource) systems
• Microsoft Office Suite or similar productivity tools

Work Environment

• Clinical research site environment supporting active clinical trials
• Collaboration with investigators, sponsors, and research staff
• Fast-paced environment managing multiple concurrent studies

About Prime Clinical Research

Prime Clinical Research is a clinical research organization dedicated to advancing medical innovation and expanding patient access to emerging therapies. Through partnerships with pharmaceutical companies, biotechnology organizations, and contract research organizations, the organization conducts clinical trials that support the development of safe and effective treatments.

Prime Clinical Research is committed to maintaining the highest standards of patient safety, regulatory compliance, and research integrity while delivering high-quality clinical trial outcomes.

Prime Clinical Research is an Equal Opportunity Employer.