Job Title: CLINICAL QUALITY ASSURANCE MANAGER (GCP) Department: Clinical, QA Philogen S.p.A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance.
On this regard Philogen is looking for a "Clinical Quality Assurance Manager (GCP)" .
The position will be responsible to assess compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols.
This position will collaborate with other functions in the Clinical Department.
In particular the successful candidate will be responsible to: Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US.
Write and/or review clinical SOPs and support continuous process improvements.
Manage training of staff on company procedures, GCP regulations, and documentation systems.
Qualify CRO and other vendors related to the clinical activity.
Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator's Brochure, CRFs, etc.)
as appropriate.
Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines.
Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues.
Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
Lead role to prepare company and clinical sites for customer audits and regulatory GCP inspections.
Participate as Subject Matter Expert during regulatory GCP inspections.
The ideal candidate should have: A good scientific background (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.).
Ideally 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required).
A complete understanding and application of principles, concepts and practices of clinical research procedures is required.
A high level of English language, both written and spoken.
A high level of attention to detail.
The ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members.
Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges.
Job location: Sovicille, Siena Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address ******, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
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