Clinical Project Manager

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Chiesi Research & Development is seeking a Clinical Trials Manager to coordinate the operational management of assigned projects, ensuring development of compounds in line with Chiesi’s goals and medical/scientific standards.Responsibilities
- Accountable for coordination of the operational management of assigned projects to meet scientific and medical standards.
- Communicate progress of the study to all stakeholders.
- Maintain and respect the budget according to the signed contract.
- Manage 1‑3 clinical trials, depending on size, complexity, phase and therapeutic area.
- Manage Clinical CRO/Providers and act as primary contact for the CRO and internal customers.
- Represent the Study Team for the operational part of the clinical trials allocated to you.
- Ensure adherence to scope of work within timelines and budget.
- Review study‑related documents prepared by the CRO (project plan, monitoring plan, risk management plan, site contracts when required) and perform co‑monitoring when specified in SOP.
- Collaborate in setting up and maintaining the Study Risk Register;




conduct clinical risk reviews with all relevant study functions and follow up on actions with vendors (CRO, direct and third‑party vendors).
- Manage the study eTMF (clinical operations) with the Clinical Trial Administrator (CTA).
- Prepare and coordinate scientific meetings: investigators’ meetings, scientific/safety board meetings, data reviews and other relevant meetings.
- Manage the preparation of experts/KOL contracts when an expert is dedicated to the study.
- Prepare and review the Clinical Study Report (CSR) in cooperation with the Medical Writer, and obtain approval.
- Support and/or coordinate the presentation of clinical study results internally and externally.
- Liaise with the Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan and manage the CTS once delivered to sites.
- Ensure compliance with SOPs and all necessary quality standards;
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ba0zg