Clinical Trial Administrator

Ipsen•Cambridge, MA

5d•$67,500 - $99,000

About The Position

The Clinical Trial Administrator supports Clinical Operations objectives by coordinating and administering clinical trial activities across the study lifecycle. Working closely with Clinical Project Managers (CPMs) and Therapeutic Area Directors, the role helps ensure effective study execution, maintenance of study documentation and systems, regulatory compliance, and inspection readiness. The administrator also performs and coordinates assigned study activities under the direction of CPMs and Clinical Operations managers to support successful and compliant trial delivery. The position encompasses Trial Master File (TMF) setup, maintenance, quality oversight, reconciliation, and archiving; financial document follow-up; transparency and expense reporting; clinical study tracking system updates; and coordination of contracts, legal and insurance documents, study materials, meetings, and administrative logistics. The role supports the Clinical Study Report process by collecting appropriate appendices and maintains shared electronic study sites. The annual base salary range is $67,500–$99,000, and the role is eligible for the short-term incentives program.

Requirements

At least 4 years of related professional experience.
Experience in a global clinical study environment within a service provider or pharmaceutical company.
Knowledge of the clinical study environment and strong theoretical or practical administrative organization.
At least a two-year degree, or related work experience and training, as stated in the minimum education requirement.
Fluent in English.

Nice To Haves

Strong experience in a global clinical study environment within a service provider or pharmaceutical company.
A three-year degree in an administrative or scientific domain.

Responsibilities

Set up and administer electronic and/or paper Trial Master Files, including country and site binders and study milestones.
Prepare and customize TMF management plans and master indexes with the CPM and document owners.
Notify the eTMF Support Team of changes to study team membership.
Maintain current TMF records and ensure essential documents are appropriately filed.
Oversee service provider and Ipsen TMF activities in accordance with Ipsen standard operating procedures.
Coordinate TMF quality checks, present results, follow up on corrective actions, reconcile the final TMF, and archive it according to applicable procedures.
Escalate critical TMF issues to the CPM or Clinical Operations managers.
Track invoices against vendor contracts and study progress, and recommend approval decisions to the CPM.
Support purchase order initiation in the finance system when required.
Collect and track reportable transfers of value to healthcare professionals and organizations in accordance with applicable transparency requirements.
Ensure service providers complete data collection templates, review submitted data, record information in the COLLECT system, and implement corrective actions as needed.
Validate transfers of value in COLLECT in accordance with disclosure timelines and create new HCP/HCO records when needed.
Check healthcare professional disclosure consent where applicable and liaise with Local or Global Transparency Managers to ensure required information is tracked.
Update clinical study tracking systems at study, region, and site levels, including study status, site setup, contacts, recruitment, and milestones.
Provide tracking templates and instructions to service providers, validate their information with the CPM, and update study systems monthly.
Perform data entry when automatic uploads are unavailable and ensure study team contacts and handovers are tracked.
Generate contract templates in ARIBA, follow contracts through signature, and file and archive executed contracts.
Collect and follow up on legal administrative documents, including powers of attorney, letters of authorization, and confidentiality disclosure agreements.
Ensure insurance certificates and renewals are requested before study start-up and throughout the study as needed.
Support medical writers by collecting appropriate Clinical Study Report appendices, including investigator CVs and lists of ethics committees and participating investigators.
Set up and maintain shared electronic study sites, such as SharePoint sites.
Arrange logistics for sponsor meetings, including invitations, room bookings, and meals.
Attend study team meetings when appropriate and prepare minutes for team review.
Adhere to company policies and act as a role model for company values; perform additional duties as assigned.