Study Project Manager

Evidilya; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading Contract Research Organization is seeking a Study Project Manager to oversee clinical trial activities. The role involves managing the study timeline, acting as the liaison between the CRO and sponsors, ensuring compliance with regulations, and overseeing budget analytics. The ideal candidate holds a scientific degree and possesses excellent organizational and communication skills. Fluency in English is required, and experience with CTMS tools and EDC software is a plus.

Competenze

• GCP-ICH and Project Management training are a plus.
• Experience in managing clinical trials or RWE studies is preferred.
• Strong knowledge of regulatory submissions and compliance.

Mansioni

• Manage all clinical trial activities and operate tasks.
• Act as contact point between CRO and sponsors.
• Lead study start-up including regulatory submissions.
• Draw-up and manage Trial Master File and center files.
• Ensure compliance of TMF and TCF with regulations.

Conoscenze

Excellent communication skills

Organizational skills

Time management skills

Decision-making skills

Fluent in English

Formazione

Scientific Degree

Strumenti

CTMS tools

EDC software

Descrizione del lavoro

Overview

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. We are 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 (e.g.: 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").