Clinical Project Manager

1 settimana fa

Italia Barrington James Limited A tempo pieno

Position Title: Clinical Project Manager - Respiratory

Reports To: Clinical Operations Lead

Location: Italy, France, Sweden

Role Summary:

Responsible for the oversight and operational management of assigned clinical projects to support the development of compounds in alignment with organizational goals and scientific standards. The role includes managing communications with stakeholders, adhering to project budgets, and ensuring compliance with relevant regulations and company procedures.

Key Responsibilities:

  • Operational Management:

    Make strategic decisions to initiate and complete clinical projects on time, within budget, and to quality standards, while ensuring compliance with ICH guidelines, company SOPs, and local regulations. Participate in the development and revision of SOPs and work instructions as needed. Complete all required training on processes and procedures.

  • Project Management:

    Develop the clinical synopsis, protocol, and associated documents based on the Clinical Development Plan, engaging key contributors. Collaborate with team members to ensure timely completion and review of essential study documents. Participate in the selection of CROs and other service providers by implementing the Request for Proposal (RFP) process, evaluating bids, and reviewing the scope of work and budget. Manage the relationship with the Clinical CRO and other vendors, acting as the primary point of contact for internal and external stakeholders. Perform co-monitoring when necessary and coordinate with Site Engagement Managers to optimize site performance. Lead the setup and maintenance of the study risk register, conduct ongoing risk assessments, and coordinate follow-up actions with vendors. Organize and contribute to scientific meetings such as investigator meetings, data review sessions, and safety boards. Ensure the study is registered on public clinical trial registries (e.g., clinicaltrials.gov, European databases).

  • Clinical Trial Supplies:

    Collaborate with the Clinical Trial Supply coordinator to establish the supply strategy, including reviewing study labels and information leaflets.

  • Study Documentation:

    Oversee the management and quality control of the study eTMF (electronic Trial Master File) in collaboration with the Clinical Trial Administrator, ensuring the completeness and proper archiving of all study documentation.

  • Budget Management:

    Monitor and reconcile study budgets, provide regular forecasts, and review invoices monthly. Conduct biannual budget forecasting in line with project progress.

  • Study Results and Publications:

    Coordinate the preparation and review of the Clinical Study Report (CSR) with the Medical Writer, ensuring approval from relevant stakeholders. Support the internal and external presentation of study results and assist with the development of manuscripts for publication.

Qualifications:

Education: Degree in Life Sciences or an equivalent field.

Experience: At least 5 years in a similar role within a pharmaceutical company or CRO, with a proven track record in planning and executing at least five clinical trials. Experience in centralized system setups and large-scale respiratory clinical trials is highly valued. Ideally experience managing Respiratory Clinical Trials.

Skills:

Core Competencies: Planning and Organizing, Problem Solving, Results Orientation, Priority Setting, Responsiveness, Teamwork, Time Management, and Decision Making.

Managerial Skills: Cost/Benefit Analysis, Quality Orientation, Leadership, Interpersonal Skills, Written Communication, Conflict Resolution, Motivating Others, and Strategic Thinking.

This role demands a proactive approach to project management and a strong focus on meeting clinical and business objectives while fostering a collaborative team environment.

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