What are the responsibilities and job description for the Site Management Lead position at Advanced Clinical?
Location: Remote
Travel: Up to 50%
Key Responsibilities
Travel: Up to 50%
Key Responsibilities
- Act as the main point of contact for clinical sites, ensuring effective collaboration and a superior site experience.
- Oversee site start-up activities: site identification/qualification, regulatory document collection, informed consent customization, IRB/EC submission review, and clinical trial agreement execution.
- Drive patient recruitment, enrollment, and timely database locks aligned with study goals.
- Provide oversight of CRO and internal site monitoring activities, including issue escalation, trend analysis, and inspection readiness.
- Conduct onsite and remote monitoring oversight visits, ensuring compliance with GCP, SOPs, and study objectives.
- Monitor site and country-level performance metrics; identify risks and implement mitigations.
- Serve as a communication bridge between sites, vendors, and study teams.
- Build and maintain strong professional relationships with investigators, study coordinators, and site staff.
- Support development of new clinical research sites and maintain libraries of regional requirements.
- Collaborate cross-functionally to resolve barriers and optimize study delivery.
- Computer literacy and ability to use clinical systems and tools.
- Strong communication skills—both written and verbal.
- Analytical mindset with problem-solving abilities.
- Proven leadership in CRA or site monitoring oversight roles.
- Knowledge of regional clinical research guidelines and regulations.
- Strong interpersonal skills with the ability to influence and drive change.
- Capable of thriving in a fast-paced, matrixed environment.
- Bachelor’s degree in Science, Healthcare, or related field (advanced degree preferred).
- 6 years’ clinical monitoring/field monitoring experience.
- 3 years in a lead CRA, CRA manager, or trial/project management role.
- Experience in a monitoring oversight capacity strongly preferred.
- Willingness and ability to travel up to 50%
