Overview In this role you oversee site-level activities for Phase I-III trials, ensuring regulatory compliance and effective conduct. You collaborate with clinical study teams to optimize site performance, recruit participants, and train investigators. You contribute to site development, budgeting, and issue resolution, while maintaining up-to-date knowledge of global regulatory expectations. This position offers the chance to shape multi-site trial execution within a pharmaceutical/biotech context and to work closely with regional teams to deliver study milestones.
Responsibilities- Execute and manage site-level activities for Phase I-III trials at assigned sites
- Ensure regulatory and policy compliance for studies at sites
- Support budget negotiation and site contracts; ensure payment for services
- Develop and implement patient recruitment strategies to meet targets
- Collaborate with Clinical Study Teams to resolve site or study execution issues
- Identify and develop investigator sites to meet recruitment needs
- Monitor site quality and performance; devise optimization solutions
- Ensure site availability, infrastructure, and capabilities align with study needs
- Communicate safety issues promptly to investigators and teams
- Develop corrective action plans for quality issues at sites
- Train and qualify sites and Principal Investigators
- Maintain knowledge of country regulations and global trial standards
- Perform monitoring activities per protocol and guidelines
- Adhere to client processes and performance metrics
- Adapt to changing work environment and milestones with strong communication
- Build positive relationships with principal investigators and site staff
Key requirements- Nine years of related experience
- Five years of direct regional field clinical monitoring/research
- Preference for current regional position from home office
- Excellent verbal and written communication, problem solving, and team orientation
- Travel approximately 60%
- Education in medical, pharmaceutical, biology, chemistry or RN preferred
- strong communication
- problem solving
- team orientation
- Microsoft Office proficiency (Outlook, Excel, Word)
- Electronic Data Capture (EDC) systems (Medidata RAVE preferred)
- Clinical Trial Management System experience (Medidata CTMS preferred)
