6 Sanofi Team Lead Jobs

Main responsibilities:

The Registry Project Leader (RPL) is responsible for the regional oversight on start-up and follow up activities as well as project oversight of the CPL and CRA within the region for the Rare Disease Registries in close collaboration with the Global Operations Lead - Rare Disease Registries and Medical Affairs staff in the countries. The RPL has responsibility for rare disease registries according to Company and Sponsor Standard Operating Procedures, and local regulatory guidelines.

This position will ensure timely support for the below activities in consultation with the Global Operations Lead - Rare Disease Registries and Medical Affairs staff.

Project Management: Responsible for oversight of all the Registries in the assigned region.

Study Start-up Activities:

Safety & Quality:

Responsible for training or arrange training for new CPLs/CRAs (if applicable)

Responsible for Training (train the trainer) additional resources hired on a temporary basis in the countries. (if applicable)

To maintain tables, trackers, and databases to follow the study progress regionally and globally.

To know and use all the tools needed.

Support the improvement of internal processes by providing feedback on e.g., CAPA, and (re)writing Quality Management System (QMS) and/or project specific documents.

To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in filing regional documents as required.

Study Meetings: To participate with the rest of the study team in local and international investigators meetings (where required), study/operational meetings, quality audits and inspections for the registries, study set-up meeting and trainings.

Liaise with Vendor for different activities (startup, onsite monitoring).

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