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 Manager
Main 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 knowledge
Candidates are invited to send their curriculum vitae and Cover letter authorizing the processing of personal data pursuant to art. 13 of Regulation (EU) no. 2016/679 (\"GDPR\")