Clinical Operations Lead
Core
Provide clinical operations oversight for GI clinical trials at a regional or global level, managing CRA activities, investigator sites, and study deliverables to ensure compliance with protocols and regulations.
Role type
Senior Clinical Operations Lead (hands-on IC)
Builds
End-to-end GI clinical trial services for patients with gastrointestinal diseases
Domain
Clinical Research / Gastrointestinal Therapeutics
Required skills
Clinical monitoring, site management, ICH-GCP compliance, recruitment strategy, CRA oversight, study planning, vendor management, regulatory knowledge, data collection oversight, TMF management
Preferred skills
SoCRA or ACRP certification, Bachelor's degree in Health/Life Sciences/Nursing, 7-9 years total experience, experience with EDC systems
Technologies
EDC systems, Microsoft Office
Responsibilities
Provide oversight of regional CRAs and investigator sites; Conduct co-monitoring and CRA assessment visits; Monitor site and country performance including recruitment and data collection; Oversee regional site start-up and feasibility; Review monitoring visit reports for quality and compliance; Provide training and mentoring to CRAs; Develop enrolment and recruitment strategies; Support clinical project team with operational objectives
Seniority
Senior, hands-on IC