Clinical Trial Assistant
Il y a 2 mois
**Title**:
Clinical Trial Assistant
**Company**:
Ipsen Innovation (SAS)
- Support the clinical project management and monitoring of clinical studies, including liaison with, monitors, CROs, drug vendors, central laboratories and other vendors for study related tasks.
- Be an active member of the study team and take responsibilities for service provider oversight for his/her scope of responsibility according to Ipsen procedures
- Be responsible for monitoring, verifying and archiving the Trial Master File as per Ipsen SOPs, instructions and trainings. This includes review and QC check of the TMF to ensure quality and completeness in view of audit, inspection and archiving.
- Be responsible for follow up and review of financial documents, in collaboration with Ipsen GCPM.
- Create and update financial information within Ipsen financial systems (SAP, K2) as need be as per study progress and service provider contract modification (commitment request, Internal Order, Purchase order, goods receipt & invoices).
- Create and update financial trackers, follow up of invoices and delay in payments
- Help to prepare forecast and assist at quarterly review meetings of study budget with GCPM and local finance controlling department
- Complete files for Transparency Office requirements (France, EFPIA, US) or receive and check against study activities in collaboration with the GCPM, and forward files from Service providers and final uploading into Ipsen Transparency Tool and for validation (Collect)
- Coordinate and conduct in-house and external clinical operations activities: study team meeting preparation, service provider contract signature collection using adequate tools for signing and storage, study insurance request and renewal via appropriate digital platform, clinical supplies shipment coordination if applicable, collect Legal administrative documents required for study conduct (POA, LOA, CDA’s, Kbis )
- Creation and maintenance of working shared space for internal and external study team member, as per Ipsen IT practices ( OneDrive, Sharepoint, Box etc)
- Responsible for data entry and status updates within the Clinical Trial Management System Data Entry: CTMS using a Clinical Manager technical role for the assigned studies, with support of GCPM or Clinical Monitoring lead (CML) as needed.
- To perform any other activity as may reasonably be required by the Manager to ensure the accurate, quality and timely execution of clinical studies.
- To complete all of the above activities within the framework and in compliance with R&D SOPs and other documentation in force within the Ipsen Group.
- EHS responsibilities and missions:
- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training
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