Job Title: Clinical Site Manager

Job Description

The Clinical Site Manager oversees day-to-day operations at clinical research sites to optimize performance and drive achievement of organizational goals. This role ensures that both sponsors and participants receive high-quality service, that contractual obligations are met, and that all work is completed in a professional, ethical, and compliant manner. The Clinical Site Manager collaborates closely with site leadership and investigators to plan and execute studies, resolve operational issues, and continuously improve site quality, recruitment, and retention.

Responsibilities

• Review and discuss awarded studies with the Principal Investigator to support leadership in making informed decisions about which studies to conduct.
• Collaborate with site leadership to assess and plan staffing needs required for successful study conduct.
• Work with site leadership to ensure the site has appropriate space, staff, and time to optimize study conduct, particularly participant recruitment and retention.
• Manage clinic operations by working closely with site leaders on staff management and resource allocation.
• Demonstrate strong knowledge of clinical research, sponsor expectations, and industry standards, and use this knowledge to guide site operations.
• Lead site staff in ongoing professional growth and high performance, fostering a culture of excellence.
• Participate in hiring high-quality candidates for positions within the site and ensure a thorough onboarding process.
• Ensure that site staff are qualified and adequately trained for their roles and assigned duties.
• Work with site leadership to plan for upcoming studies and ensure operational readiness.
• Ensure that site staff and investigators are informed of awarded studies and understand their responsibilities.
• Monitor staff performance, hold staff accountable to role expectations, and provide timely performance feedback.
• Ensure staff comply with study protocols, FDA regulations, ICH guidelines, and internal standard operating procedures and policies.
• Monitor overall site quality and performance and develop and implement solutions to optimize outcomes.
• Monitor study needs and provide hands-on support to staff with study conduct and management as needed.
• Manage staff schedules to optimize site performance and ensure adequate coverage for study activities.
• Collaborate with site leadership to address disciplinary issues and HR concerns such as misconduct, policy violations, and workplace conflict.
• Ensure staff compliance with the company Employee Handbook and organizational policies.
• Build and maintain strong working relationships with investigators in collaboration with site leadership.
• Ensure adequate investigator coverage to support optimal site visits and study conduct.
• Collaborate with investigators to promote study success and resolve operational or clinical issues.
• Manage site quality control processes, including monitoring adherence to SOPs and implementing corrective actions when necessary.
• Monitor site staff to ensure the highest quality performance and adherence to Good Clinical Practice and FDA regulations and guidance, taking immediate corrective actions as needed.
• Serve as an active team member, communicating effectively and professionally with other team members in a timely manner.
• Represent the site and organization in a professional, ethical, and positive manner and promote harmony and professionalism in the workplace.
• Acquire and maintain required training, including SOPs, processes, and policies training, Good Clinical Practice training, and IATA Shipment of Hazardous Goods training (if applicable), according to defined schedules.
• Participate in study-specific training as required and maintain any relevant medical licenses and certifications.
• Ensure the site is fully prepared for study conduct, including facilities, staff, documentation, and supplies.
• Ensure appropriate staff attend investigator meetings and site initiation visits and are adequately briefed on study requirements.
• Ensure all staff participating in a trial receive appropriate training for their delegated tasks.
• Oversee timely creation and review of source documents to support accurate data capture.
• Work with regulatory staff to manage essential documents and complete site-level regulatory duties, including continuing reviews and study closeouts.
• Disseminate study-related information to site personnel and potential participants in a clear and timely manner.
• Ensure the site obtains all required documents and equipment needed to conduct each study.
• Ensure sp