NMS Group is the largest company in Italy, committed to innovation and research in oncology. Nerviano Medical Sciences srl, representing the innovative core of the group, is looking for a CLINICAL TRIAL MANAGER.
Main Responsibilities
The position reports to the Head of Clinical Operations and will be a key team member, leading a team of four colleagues. It involves coordinating cross-functional teams dedicated to clinical trials.
The main purpose is to lead and coordinate activities for the successful implementation of multi-country early-phase oncology clinical trials, ensuring the continuous availability of up-to-date and reliable data.
Key Tasks
* Assess project feasibility from an operational perspective.
* Lead the Clinical Trial Team (CTT), ensuring documentation readiness for meetings and liaising with team members such as CRAs, Data Managers, PV Managers, and Regulatory Affairs Managers.
* Participate in cross-functional meetings, supervise contractors and collaborators involved in clinical operations.
* Contribute to investigator and site selection based on project needs.
* Advise on project budgets and contractual arrangements for investigators and sites.
* Assist in preparing clinical trial documents for regulatory submissions and ongoing maintenance.
* Ensure study manuals and plans are prepared and updated appropriately.
* Maintain and archive study documentation, perform study setup, review, and updates in the Veeva system.
* Provide project-specific training to relevant staff.
* Supervise monitoring activities related to the project.
* Oversee protocol deviations, assess their impact, and coordinate corrective actions.
* Contribute to activities related to Investigational Medicinal Products (IMPs) and manage drug recalls and safety measures as needed.
Qualifications
* Scientific degree (Biology, Pharmacy, Chemistry).
* Fluent in English, written and spoken.
* At least 5 years of experience as a Clinical Trial Manager or Clinical Project Manager in early oncology clinical development, preferably in pharmaceutical companies, CROs, or biotech, with responsibility for multi-country trials in the EU and US.
* Excellent organizational, planning, and problem-solving skills.
* Strong interpersonal skills and ability to work in complex international environments.
* Team-oriented with good project management skills.
* Ability to multitask, build relationships, and work cross-functionally.
* Proficiency in conducting technical and economic feasibility analyses with a sense of responsibility.
Location
The position is based in Nerviano (Milan) and can be performed remotely up to two days per week.
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