ClinicalStudyCoordinator(H/F)

participate in the management of clinical trials through the activities delegated by the CSMs, Support the CSM in coordinating clinical trial team to successfully conduct required activities, Ensure the follow-up of actions defined during clinical trial team meetings, Participate in the drafting/review of clinical trial documents (e.

Informed Consent forms (ICFs), protocol, protocol amendments, safety management plan), Contribute to the development of regulatory and administrative documents, ensuring their follow-up and updates (e.

training log, TMF management plan, trial document inventory and change control), Request and monitor clinical trial insurance, Participate to the review of the regulatory package submission, Actively contribute that the clinical trials are performed according to the GCP, standard operational procedures, and in compliance with Pierre Fabre ethical rules, Actively participate in CRO oversight (e.

by defining and preparing performance indicators for subcontracted activities, reviewing CRO reports, reviewing the monitoring visit reports, etc…), Contribute to the logistical follow-up of clinical trial materials, Support in setting up a clinical trial oversight plan with internal stakeholders, Assist in organizing key meetings related to the clinical trials, including drafting and distribution of meeting minutes, Participate in budget monitoring of clinical trial (e.

invoices check, update of budget trackers), Ensure the update of tools and dashboards for clinical trial management, Ensure that the TMF is inspection-ready throughout the clinical trial in compliance with GCP by ensuring quality checks, Ensure the creation, classification, and archiving of the Trial Master File according to the current procedure.