Clinical Study Leader
posted by: spj_bot
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
The Clinical Study Leader (CSL) oversees the operational execution of Phase 1/2 clinical trials across multiple countries, ensuring delivery on time, within budget, and to quality standards. Acting as the main operational contact, the CSL works closely with CROs, vendors, and reports to the Project Director.
Main Responsibilities:
- Lead and coordinate the cross-functional clinical study team
- Ensure on-time delivery of key study milestones
- Monitor study progress, identify risks, and drive mitigation actions
- Ensure compliance with protocol, ICH-GCP, and regulatory requirements
- Act as main sponsor contact and oversee CRO performance
- Manage external vendors, including deliverables and issue resolution
- Contribute to study planning and development of key documents
- Ensure study start readiness (sites, systems, supplies) and track budget/resources
- Maintain clear communication, escalate issues, and ensure quality and inspection readiness
Requirements