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.
• Support the initiation, preparation and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, pharmacy, clinical supply and laboratory related documents, etc.).
• Study Trial Master File (TMF) oversight - ensures required study documents received, reviewed and filed in the TMF in accordance with GCP and applicable regulations.
• Organise study related meetings including preparation of agenda/minute taking and maintenance of risk/issue/decision logs (leading and presenting at study-related meetings as necessary).
• Support and participate in departmental, study team, and service provider related meetings.
• Participate in study related collaborative efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.).
• Complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.
• Support, track and triage site and service provider queries.
• Support rapid actions to address both internal and site QA findings from audits.
• Manage, coordinate and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, implementation, etc.
• General study tracking and maintenance, including study status, enrolment, deviations, study level documents and plans.
• Support oversight of clinical site performance, metrics, monitoring visits.
• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews.
• 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 (contract and invoice reconciliation).

Associate Clinical Operations Leader – FSP

Freelance/Contract Clinical Project Manager

Associate Clinical Operations Leader – FSP

Senior Manager, Business & Strategic Operations – Global Clinical Operations