Clinical Trial Associate
Il y a 6 mois
**Purpose of the position**
- Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
- Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
- Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU)
- Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures. Includes liaison with service providers in regards Ipsen e-TMF process and resolving issues related to missing documentation
- Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection
- Contributes to clinical trial excellence initiatives
**Main responsibilities and 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 appropriate role of all study team members (CRO/Ipsen) newcomers 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, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant Ipsen study team members.
- Coordinate the TMF Quality Check (per Ipsen SOP) with the CRO/Ipsen to ensure the eTMF inspection readiness.
- Coordinate the final TMF reconciliation with the CRM/CPM.
- In charge of archiving the TMF
**Be responsible for follow
- up and review of financial documents, in collaboration with CRM/CPM**
- Create and update financial information within the Ipsen financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team
- 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 quarterly 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 to the CRO together with instructions to get all the necessary information monthly to feed the Ipsen eCTMs (Hermès)
- Update the eC
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