.If you are an experienced Clinical Trial Manager who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!
Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting.
Our passionate team is committed to providing cancer treatments of the future to the world of today.TRIO is looking for a Clinical Trial Manager to join our Project Management team.
Reporting to the Senior Clinical Trial Manager (SCTM), Global Project Coordinator (GPC) or Clinical Trial Manager (CTM) with a Study Lead role, this position will be remote-based.Responsibilities: This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor:Provides support to the CRAs and the sites by:Reviewing and approving monitoring reports within the agreed timelinesEnsuring any detected issue (Protocol Deviation or non-Protocol Deviation) is reported in the Clinical Trial Management System and is adequately followed until closurePreparing/reviewing training materials for the Global CRA calls and performing presentationsParticipating in the preparation of global communications to the CRAs/SitesAnswering any questions the CRAs and sites have during the trialFollowing on trial activities with CRAs (+/- sites directly if needed)Oversees activities conducted by regional Third Party Organizations (TPOs)Prepares, or oversees, the submission of the documents to the Ethics Committee and Regulatory Authorities (if applicable)Ensures appropriate TMF maintenance by:Reviewing, approving, and submitting the essential documents at country level for filing in the TMF and identifying missing documentsPerforming periodic review of the Trial Master File (TMF Quality Controls (QCs) at country/site levels and following up with the support of the CTAs on any detected finding until resolutionOverseeing the periodic review of the TMF performed by the CTAsMaintains information up to date in the Clinical Trial Management System (CTMS)May provide expertise and functional supervision of the CTA(s) tasksNegotiates amendments to financial agreements with investigators/sites as per trial requirementsReviews and approves invoices (e.G