
Clinical Quality Assurance Manager
Paris, France
Reference number: CQAM1
Genesis Pharma are currently looking for a Clinical Quality Assurance Manager to join a leading Pharmaceutical company based in Paris. Full time position with fantastic benefits available to all employees from day 1 and high competitive salaries.
Missions
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Set up, monitor and follow up on our plan to audit clinical systems and sites worldwide.
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Coordinate site audit activities with external audit partners.
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Manage the preparation of audits and inspections. Implement and follow up with all internal and external stakeholders the implementation of the resulting action plans.
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Participate in the writing of essential clinical trial documents, leading in updating procedures.
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Develop the training required for the proper conduct of our studies in compliance with regulations and PCBs.
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Quality internal consultant for our teams mainly monitors and project managers.
Profile
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Holds a Bac +4/5 scientific degree and a training in Clinical Research
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Expert in Good Clinical Practice ref. ICH and FDA BPC guidelines
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Successful experience in monitoring clinical studies in a pharmaceutical or CRO laboratory
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Five years minimum clinical experience
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Minimum one year as clinical site auditor
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Control of the regulatory environment for clinical trials
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Fluent English
Modalities
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CDI to be filled as soon as possible
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Post based in Paris, with some possible displacements
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Salary to be defined according to profile and experience
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To apply for this role, find out more about this or other roles, please forward your most up to date CV to Natalie.hough@genesisglobalgroup.eu and a member of the Genesis Pharma team will be in contact as soon as possible.
TAGS: Quality Assurance