Clinical Trial Administrator

Ipsen Biopharmaceuticals Inc. is hiring a Clinical Trial Administrator to coordinate and administer clinical trial activities across the study lifecycle. The role supports study execution, documentation and systems maintenance, regulatory compliance, financial and transparency tracking, and inspection readiness in collaboration with Clinical Project Managers and study teams.

Responsibilities

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

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

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

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

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

Preferred

Ideal: Strong experience in global clinical study environment within SP or Pharmaceutical company

Ideal: 3-year degree in an administrative or scientific domain

Global Clinical Study Experience

Service Provider Experience

Scientific Degree

Benefits

This job is eligible to participate in our short-term incentives program.

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

A discretionary winter shutdown

Well-being allowance

Commuter benefits

Company

Biopharmaceutical medicines for oncology, rare disease, and neuroscience

Paris, Ile-de-France, FRA

http://www.ipsen.com/

Founded in 1929

5001-10000 employees

Qualifications

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

Minimum: 2-year degree of related work experience and training

Fluent in English

Ideal: Strong experience in global clinical study environment within SP or Pharmaceutical company

Ideal: 3-year degree in an administrative or scientific domain

Required skills

Represents the skills you have, click on the tags

Experience

4+ years