What You'll Do
Oversee and execute critical site activities including selection, initiation, routine monitoring, and close-out visits to ensure studies progress smoothly. Conduct thorough reviews of case report forms and verify source documents to maintain data accuracy and resolve discrepancies efficiently.
Serve as the primary contact for clinical sites, managing communication and ensuring timely transmission of information between local teams and study locations. Lead country-level project meetings to align objectives, track enrollment progress, and support adherence to established timelines.
Collaborate with feasibility teams to assess site capabilities and contribute to study planning. Assist regulatory departments by preparing essential documentation for submissions, and actively prepare for and participate in audits and inspections to uphold compliance standards.
Requirements
- Proven experience in clinical monitoring across multiple therapeutic areas
- Strong understanding of GCP, ICH guidelines, and regulatory requirements
- Ability to manage site relationships and drive recruitment efforts
- Experience with CRF review, source data verification, and query resolution
- Skill in leading team discussions and coordinating cross-functional input
Benefits
This position supports local operations with structured flexibility in a regulated environment. Compensation includes a competitive salary and potential for additional financial components. Work is conducted primarily within the country, aligned with regional project needs and compliance frameworks.
