Clinical Trial Associate

**Title**:
Clinical Trial Associate (CTA) H/F

**Company**:
Ipsen Pharma (SAS)

To assist in the delivery of Clinical Development objectives and achieve Clinical Operation Excellence, mainly by supporting the Clinical Research Manager (CRM)/Clinical Project Manager (CPM) in administrative activities within the conduct of the clinical studies.

To also perform and/or coordinate, on request, some non-administrative specific clinical study tasks under the direction of the CRM/CPM and Program Director/Head of ClinOps.

Main responsibilities and tasks

**Main Responsibilities**

**Main Tasks**

**Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)**
- In charge of the Ipsen electronic TMF (and/or paper TMF, 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 Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners.
- Inform the eTMF User Support 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 up-to-date and all essential documents are appropriately filed in the TMF.
- Perform continuous oversight of the CRO/Ipsen TMF activities, according to Ipsen SOP.
- Coordinate the TMF Quality Check (as per Ipsen SOP) with the CRO/Ipsen to maintain data integrity and to ensure eTMF inspection readiness.
- Present the results of the quality check to service provider and to study team.
- For all findings ensure that corrective actions are performed according to defined timelines.
- Coordinate the final TMF reconciliation with the CRM/CPM.
- In charge of archiving the TMF according to paper TMF/e-TMF SOP.
- Escalate any TMF critical issues to Program Director/Head of Clinical Operations.

**Be responsible for follow
- up and review of financial documents, in collaboration with CRM/CPM**
- Create and update financial information within the Ipsen financial system (K2, SAP,) (Internal Order, Purchase Order, goods receipt & invoices), or managed by a dedicated position, if available.
- Create and follow-up of the clinical study Commitment Requests within the Ipsen dedicated tool (K2).
- Create and update the specific clinical study budget trackers.
- Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM.
- Follow up of the clinical study invoices to secure payments in time. Support, if necessary, the CRM/CPM in the clinical study budget such as forecast preparation, attendance to study financial review meetings,

**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 (Collect).
- Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
- Check the data received from the CROs with the support of the CRM/CPM.
- Ensure the information is properly recorded in the COLLECT system, implement corrective actions where needed.
- Ensure the Transfers of value collected (directly or via the CROs) 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) to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system.

**Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)**
- When assigned on a study, get access to the study record in eCTMS.
- Check the eCTMS study data using the Clinical Operations Reporting (i.e. Clinical Operations Dashboard, CSS Monthly Report) and update as applicable (at study/region/site level: status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CRM/CPM for the monthly report purposes.
- Ensure the study team contacts and handovers are properly tracked in eCTMS.
- Provide the excel tracker template to the CRO together with instructions to get all the necessary information monthly to feed the Ipsen eCTMs (Hermès).
- Update the eCTMS monthly with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable).

**Coordinate and conduct in-house and external clinical operations activities**
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