21 ago - Italia
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.
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.
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). 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;
Responsible for management of the Clinical CRO/Providers Acting as primary contact for Clinical (CRO) but also internal customers. 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 conduct involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors);
Prepares and coordinates/collaborates to scientific meetings: investigators’ meeting, scientific/safety board meetings, Data reviews and any other study-relevant meeting(s);
Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan Reviews the labels and leaflets;
Responsible for the management of the study eTMF (related to clinica
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as loft
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Adecco Italia