Clinical Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7eu08g

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; lead corrective and preventive actions and follow‐ups (e.g.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7eu08g