Clinical Trial Administrator

## Clinical Trial Administrator Apply locations:
Cambridge (US) time type:
Full time posted on:
Posted Todayjob requisition :
R-20817
*
* 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
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*
* 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  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),…