Clinical Trial Administrator

The Clinical Trial Administrator supports the delivery of Clinical Operations objectives through the coordination and administration of clinical trial activities across the study lifecycle. The role partners closely with Clinical Project Managers (CPM) and Therapeutic Area (TA) Director(s) in administrative activities to ensure effective study execution, maintenance of study documentation and systems, regulatory compliance, and inspection readiness within the conduct of clinical studies.

In addition, the Clinical Trial Administrator performs, and coordinates assigned clinical study activities under the director of the CPM and Managers of Clinical operations, in support of the successful and compliant delivery of clinical trials.

• In charge of the Ipsen TMF (electronic and/or paper, if applicable) set-up and administration.
• Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
• Prepare and customize the TMF Management plan, & TMF master index, according to the clinical study specificities, with the CPM and the Document Owners.
• Inform the eTMF Support Team of any modification of the study team structure, e.g. study team members (Internal/External) new arrival or departure.
• Ensure the TMF is being maintained, kept up-to-date, and all essential documents are appropriately filed.
• Perform continuous oversight of the Service Provider (SP)/Ipsen TMF activities, according to Ipsen SOP.
• Coordinate the TMF Quality Check (as per Ipsen SOP) with the SP/Ipsen to maintain data integrity and to ensure eTMF inspection/audit readiness.
• Present the results of the Quality Check to SP and to study team.
• For all findings, ensure that corrective actions are performed according to defined timelines.
• Coordinate the final TMF reconciliation with the CPM and the study team.
• In charge of archiving the TMF according to paper TMF/e-TMF SOP.
• Escalate any TMF critical issues to CPM/Managers of Clinical Operations.

• Track invoices against SP/Vendor contracts and study progress to provide recommendation of approval (or otherwise) to the CPM.
• Support in initiation of Purchase Orders, in finance system, if required.

• Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system.
• Ensure complete data tracking by the SP with the Data Collection Template (DCT).
• Check the data received from the SP.
• Ensure the information is properly recorded in the Data Transparency system (COLLECT), implement corrective actions where needed.
• Ensure the transfers of value collected (directly or via the SP) in COLLECT are validated along the way in compliance with the disclosure timings requirements.
• When needed, create new HCP/HCO records in the COLLECT system.
• Where applicable, check the disclosure consent of Healthcare Professionals (HCPs) for each activity.
• When needed, liaise with the Local Transparency Manager (LTM) or the Global Transparency Manager. GTM is to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system.

• When assigned on a study, get access to the study records and update study tracking systems (e.g. eCTMS or other tools, as specific to study) as applicable (at study/region/site level: e.g. status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CPM.
• Provide…