On behalf of our Client, Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world with more than 80 years of experience in the pharmaceutical and biotechnology industry, IQVIA is looking for a Clinical Project Manager (fixed-term maternity cover) to join an exciting working environment in a dynamic and international atmosphere.
Purpose
The Clinical Project Manager will be accountable for the coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi's goals and medical/scientific standards.
Responsibilities
Make operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, securing compliance with ICH and Chiesi Standard Operating Procedures (SOPs) or any local regulations.
Be involved in the writing/review of SOPs and working instructions (WI). Complete assigned SOPs/WIs/processes training according to company process.
Project Management:
Develop full synopsis and protocol,
and related documents based on the Study Outline contained in the Clinical Development Plan (CDP) involving all relevant contributors.
Collaborate with relevant contributors and accountable team members to ensure timely production and review of other important study-related documents.
Contribute to CRO and/or Providers selection: responsible for implementation of the Request For Proposal (RFP); review and assess the proposals; review scope of works and overall budget.
Responsible for management of the Clinical CRO/Providers. Act as primary contact for Clinical CRO but also internal customers. Ensure adherence to scope of work within timelines and budget. Perform co-monitoring when needed, as specified in SOP and collaborate with Site Engagement Managers for study site performance and relationship consolidation.
Collaborate in the set-up and maintenance of the Study Risk Register. Responsible for ongoing clinical risk review during study conduct involvin
📌 Clinical Project Manager-Maternity Cover (Italia)
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📍 Italia