Study Project Manager...

17 ore fa


Milano, Italia Evidilya A tempo pieno

Evidilya, the dedicated Contract Research Organization of Sprim Health Group operates as a full-service international expertise in successfully developing and managing observational, pre-clinical and clinical trials in the field of Food&Nutrition, Pharma and Medtech/Medical Devices industries with a strong technological and digital footprint, is looking for a Study Project ManagerMain Tasks:- Manage all the clinical trial/RWE study activities and the, organizing the operative tasks evaluating timeframes, according to priorities, and coordinating the dedicated team (MW, DM, CRA, CTA)- Act as a contact point between the CRO and sponsors (ex: updates, potential issues, etc.)- Lead the start-up of the study, including regulatory submissions and approval, handling the recruitment and the on-boarding of the site.- Draw-up and manage Trial Master File (TMF) and Trial Center Files (TCFs)- Share regular updates with the BU Director/Clinical Operation leader on the study status (vendors, activities, timeline and project plan)- Ensure the compliance of TMF/TCF with SOPs, GCP and applicable regulations, overseeing and guiding the clinical team on the suitable policy of TMF and TCF storage and maintenance.- Support the Clinical Research Organization on the monitoring of the trials- Review and approve the monitoring reports, ensuring a quick resolution of potential issues.- Manage the budget and the cost analytics of the project.Requirements:- Scientific Degree (GCP-ICH and Project Management training are a plus)- Excellent communication, organizational, time management and decision-making skills- Fluent in English- Nice to have: CTMS tools EDC software knowledgeCandidates are invited to send their curriculum vitae and Cover letter authorizing the processing of personal data pursuant to art. 13 of Regulation (EU) no. ******** ("GDPR")


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