Clinical Project Manager

2 giorni fa

Milano, Italia PRINEOS S.r.l. A tempo pieno

**CLINICAL PROJECT MANAGER**

The Clinical Project Manager is in charge of planning and overseeing all the aspects of a delegated study/project. He/she contributes in the timelines definition and operates to meet project's goals on time and within budget. He/she establishes strategies to achieve the study commitments acting as the point of contact for the client and for the study team. He/she plans, executes, maintains oversights and reports on clinical trials, from planning, vendor selection and site feasibility, through study close out. He/she leads and provides direction to the Study Team to ensure all trial outputs.

**Tasks and responsibilities**:

- Define and drive study timelines and milestones
- Define the needs for External Service Providers (ESPs), identify and select ESPs, including negotiation of scope of work and budget and ensure that related contracts comply with internal procedures and GCP requirements
- Oversee study approval processes
- Oversee forecasting of IMP and study supplies
- Review and approve feasibilities
- Perform ongoing ESP management, performance management and issue resolution
- Work within the clinical trial core team alongside study and program leads
- Provide study specific direction to study team members and ensure that they are regularly updated on the study progress, challenges and risks through-out the duration of the study
- Provide regular study status updates including critical issues
- Track and manage assigned budgets in line with study plans
- Act as a contact for clinical trial sites
- Support the management and implementation of new clinical systems as needed
- Follow GCP and ensure compliance with local and company regulations
- Address enrolment and retention issues, identify and implement actions to keep study on track
- Ensure proper study documentation is maintained and archived
- Resolve issues in a proactive and timely fashion and escalate unresolved issues and identified risks
- Create, manage and ensure tracking of study budget including revisions and perform final

**Minimum requirements**:

- Master degree or equivalent university education/degree in life science or healthcare
- Minimum of 10 years relevant experience in clinical development and clinical trial management (field monitoring experience is preferred)
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)
- Experience selecting and managing external service providers
- Very good understanding of clinical trial budget
- Thorough understanding of the drug development process
- Advanced knowledge of ICH-GCP and other relevant clinical trial regulations
- Fluency in English, both written and oral (additional languages would be a plus)
- Communication and interpersonal skills
- Ability to negotiate and resolve conflicts

Contratto di lavoro: Tempo pieno, Tempo indeterminato

Disponibilità:

- Dal lunedì al venerdì

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