Clinical Trial Administrator

About this role

Title: Clinical Trial Administrator Company: Ipsen Biopharmaceuticals Inc.   About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.  Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/   and follow our latest news on LinkedIn and Instagram .

Job Description: WHAT - Summary & Purpose of the Position 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.

WHAT - Main Responsibilities & Technical Competencies Set-up, monitoring, verifying and archiving the clinical Trial Master File (TMF): • 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.

Follow-up and review of financial documents, in collaboration with CPM: • 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.

Tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US): • 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.

Status updates within the clinical study tracking systems: • 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 trackers/templates to the SP, together with instructions on how to get all necessary information to update the Ipsen clinical study tracking systems/tools. • Update the clinical study tracking systems/tools monthly with the SP tracker information after validation with the CPM. • Undertake data entry to the clinical study tracking system if required (e.g. if automatic upload of information is not possible). • Ensure the study team contacts and handovers are properly tracked.

Coordinate and conduct in-house and external clinical operations activities: • Generate contract templates within the Ipsen dedicated system (ARIBA), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts. • Collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorization (LOA), Confidentiality Disclosure Agreement (CDA). • Ensure insurance certificate and renewals are being requested prior to the study start-up a

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