Clinical Operations

• Support activities related to study/site feasibility, start-up, maintenance, and close-out
• Manage study and site essential document review, collection, tracking, etc.
• Supports the initiation, preparation and maintenance of core study documents
• Study Trial Master File (TMF) oversight
• Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs
• Support and participate in departmental, study team, and service provider related meetings
• Participate in study related collaborative efforts and reviews
• Complete monitoring visit report review and perform co-monitoring or monitoring oversight visits
• Support, track and triage site and service provider queries
• Manage, coordinate and oversee the activities from third party service providers
• General study tracking and maintenance
• Support oversight of clinical site performance, metrics, monitoring visits, etc.
• Assist and support study data related activities
• Review and verification of service provider activities
• Support study reporting and tracking with applicable systems and technology
• Support study leads in cross-functional alignment of study timeline and in financial management of Service Providers

Associate Clinical Operations Leader – FSP

Freelance/Contract Clinical Project Manager

Senior Manager, Business & Strategic Operations – Global Clinical Operations

Associate Clinical Operations Leader – FSP