Ipsen · 15 hours ago
Clinical Trial Administrator
Cambridge, MA
Full-time
Onsite
Mid Level
$68K/yr - $99K/yr
4+ years expIpsen is a biopharmaceutical company seeking a Clinical Trial Administrator. The role involves managing the clinical Trial Master File (TMF), ensuring compliance with regulatory requirements, and coordinating clinical operations activities.
BiotechnologyPharmaceuticalProduct Research
Responsibilities
Be responsible for setting-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
Be responsible for 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
Responsible for 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
Responsible for 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 and during the course of the study
Provide support to the medical writer with the Clinical Study Report (CSR) to secure the collection of appropriate appendices such as investigators’ Curriculum Vitae, list of Ethics Committee & list of participating investigators
Set-up and maintain shared study electronic site (SharePoint, or other tools)
Organize appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order etc) such as Investigator’s meeting, DRM & TFLs, Steering Committee
Attend study team meeting when appropriate and take meeting minutes for team review
Qualification
Required
Minimum 4 years related professional experience
Experience in global clinical study environment within SP or Pharmaceutical company
Knowledge of the clinical study environment with a strong theorical or practical administrative organization
Ideal: 3-year degree in an administrative or scientific domain
Minimum: 2-year degree of related work experience and training
English is the working environment; strong English intermediate level is necessary
Good written and oral understanding is necessary for the position
Benefits
401(k) with company contributions
Group medical, dental and vision coverage
Life and disability insurance
Short- and long-term disability insurance
Flexible spending accounts
Parental leave
Paid time off
Discretionary winter shutdown
Well-being allowance
Commuter benefits
Company
Ipsen
Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.
5001-10000 employees
H1B Sponsorship
Ipsen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$574.72M2025-03-19Post Ipo Debt· $545.59M
2017-11-20Post Ipo Equity· $29.13M
2005-12-16IPO
Leadership Team
David Loew
Chief Executive Officer
Josep Catlla
Executive Vice President & Chief Corporate Affairs Officer at Ipsen
Recent News
Pharma Letter
2026-02-13
2026-02-12
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