31 lug - Torino
IQVIA Italia
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 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.
Main responsibilities:
-Makes operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, secures compliance with ICH and Chiesi Standard Operating Procedures (SOPs) or any local regulations;
-Can be involved in the writing/review of SOPs and working instructions (WI). Completes assigned SOPs/WIs/processes trainings according to company process;
-Project Management:
- Develops full synopsis and protocol,
and related documents based on the Study Outline contained in the Clinical Development Plan (CDP) involving all relevant contributors persons;
- Collaborates with relevant contributors and accountable team members to ensure timely production and review of other important study-related;
- Contributes to the CRO and/or Providers selection: responsible for the implementation of the Request For Proposal (RFP); reviews and assess the proposals; reviews scope of works and overall budget;
- Responsible for management of the Clinical CRO/Providers Acting as primary contact for Clinical (CRO) but also internal customers. Ensures adherence to scope of work within timelines and budget. Performs co-monitoring when needed, as specified in SOP and collaborates with Site Engagement Managers for study siteperformance and relationship consolidation;
- Collaborates in the set-up and maintenance of the Study Risk Register. Responsible for ongoing clinical risk review during study c
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