Clinical Trial Administrator
Ipsen
Summary
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.
Job description
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.
Main Responsibilities & Technical Competencies
- Set-up, monitoring, verifying and archiving the clinical Trial Master File (TMF)
- 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 and TMF master index
- Ensure the TMF is maintained, kept up-to-date, and all essential documents are appropriately filed
- Perform continuous oversight of the Service Provider (SP)/Ipsen TMF activities
- Coordinate the TMF Quality Check to maintain data integrity and ensure eTMF inspection/audit readiness
- Coordinate the final TMF reconciliation with the CPM and the study team
- Track invoices against SP/Vendor contracts and study progress
- Support in initiation of Purchase Orders in finance system
- Collect and track reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs)
- Update clinical study tracking systems (e.g. eCTMS) with study status, sites, team contacts, recruitment, and milestones
- Generate contract templates within ARIBA and follow-up until contracts are signed
- Collect and follow-up legal administrative documents such as Power of Attorney, Letter of Authorization, Confidentiality Disclosure Agreement
- Ensure insurance certificate and renewals are requested
- Provide support to the medical writer with the Clinical Study Report (CSR)
- Set-up and maintain shared study electronic site (SharePoint)
- Organize logistics for Ipsen Sponsor meetings
- Attend study team meetings and take meeting minutes
Knowledge & Experience
Essential: Minimum 4 years related professional experience. Experience in global clinical study environment within SP or Pharmaceutical company. Knowledge of the clinical study environment with strong theoretical or practical administrative organization.
Preferred: Strong experience in global clinical study environment within SP or Pharmaceutical company.
Education / Certifications
Essential: Minimum 2-year degree of related work experience and training. Preferred: 3-year degree in an administrative or scientific domain.
Language(s)
Essential: Fluent in English.
Requirements
- Minimum 4 years related professional experience
- Experience in global clinical study environment within SP or Pharmaceutical company
- Knowledge of clinical study environment with strong theoretical or practical administrative organization
- Minimum 2-year degree of related work experience and training
- Fluent in English
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Parental Leave
- Paid Time Off
- Winter Shutdown
- Well-being Allowance
- Commuter Benefits
Company overview
Ipsen is a French biopharmaceutical company headquartered in Paris, France, with a global presence in over 40 countries. Founded in 1929 by Henri Beaufour, the company has evolved into a leading mid-size pharmaceutical firm specializing in three key therapeutic areas: oncology, rare diseases, and neuroscience. With approximately 5,300 employees worldwide, Ipsen operates as a publicly traded company on Euronext Paris while maintaining significant family ownership through the Beaufour family. The company's portfolio includes innovative treatments such as Cabometyx for advanced cancers, Dysport for neurological conditions, and Bylvay for rare liver diseases. Ipsen has established itself as one of the world's top 15 biopharmaceutical companies in oncology sales, with medicines registered in 88 countries and direct commercial operations in over 30 nations. The company maintains four global R&D hubs and three pharmaceutical development centers, investing significantly in research and development to advance transformative medicines for patients with limited treatment options.