Site Manager

Job Details 

Description 

Key Responsibilities 

Team Leadership & Management 

• Supervise and mentor clinical research staff, including investigators, coordinators, and laboratory personnel. 
• Organize, prioritize, and schedule work assignments to ensure optimal study execution. 
• Provide direction and support during subject screening and enrollment to achieve study targets. 
• Recruit, onboard, train, and evaluate team members, including conducting interviews and performance reviews. 
• Promote a positive, compliant, and collaborative workplace culture aligned with organizational values. 

Clinical Trials Oversight 

• Oversee the conduct of all clinical trials in accordance with FDA regulations, ICH-GCP, and organizational SOPs. 
• Ensure all personnel are trained on study protocols and assigned responsibilities prior to study activation. 
• Monitor enrollment, retention, protocol adherence, and data quality. 
• Implement corrective actions to address risks to timelines, enrollment, or study quality. 

Regulatory & Compliance Management 

• Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs). 
• Maintain complete and compliant drug and device accountability records. 
• Oversee IRB submissions, amendments, continuing reviews, and regulatory documentation. 
• Manage vendor compliance and regulatory readiness for audits and inspections. 

Operational Management 

• Implement, monitor, and report on key performance indicators (KPIs) related to enrollment, quality, and timelines. 
• Ensure accurate and timely completion of case report forms and EDC entries. 
• Lead regular staff meetings and operational reviews. 
• Serve as the primary liaison with Sponsors, CROs, and other external stakeholders. 

Financial & Performance Management 

• Understand and manage clinical trial budgets and site financial performance. 
• Track visit completion, invoicing, and sponsor payments. 
• Optimize site operations to support revenue growth, efficiency, and study profitability. 

Administrative & Support Duties 

• Maintain operational and regulatory records. 
• Provide coaching, feedback, and professional development to staff. 
• Travel to investigator meetings, sponsor trainings, and site visits as required. 
• Step in to support study coordination or laboratory functions during high-volume or staffing gaps. 

Minimum Qualifications 

Experience 

• Minimum of five (5) years of experience in clinical research; seven (7) to ten (10) years preferred. 
• Demonstrated experience in site operations or clinical trial management. 

Education 

• Bachelor’s degree in a related field required; Master’s degree preferred. 

Certifications 

• CITI training (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within the first two weeks of hire (training provided). 
• CRC certification preferred. 

Skills 

• Strong leadership, communication, and organizational skills. 
• Ability to manage multiple studies, shifting priorities, and diverse therapeutic areas. 
• High attention to detail and regulatory compliance. 

Additional Requirements 

• Ability to travel locally and nationally as required. 
• Must be based on-site at an assigned clinical research location. 
• Willingness to work flexible hours and assume additional responsibilities as needed. 

Technical Skills 

• Experience with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS). 
• Proficiency with Microsoft Teams, PDF editing tools, and DocuSign. 

Physical Requirements 

• Ability to lift, carry, push, or pull up to 10 pounds. 
• Ability to sit, stand, walk, bend, and move throughout the workday. 
• Adequate coordination and dexterity to handle equipment and assist patients safely. 

Compensation 

Salary is commensurate with experience and qualifications.