Clinical Quality Assurance Manager

5 giorni fa

Milano, Italia Heads Research A tempo pieno

At Heads we are always on the lookout for passionate people to expand our team.
Regardless if you have years of experience on your back or looking for your first job in clinical research drop us your CV and we will make sure that it is carefully looked after.
Heads, a global CRO, is seeking a Clinical Quality Assurance Manager (CQAM) based in Italy to join its growing interventional hematology/oncology clinical program.
This is a full-time position.
It could be hybrid or remote.
The CQAM has a leading role in ensuring the Company conducts clinical trials and studies to the highest quality standards, in compliance with applicable international standards, legislation, protocols, Company and Sponsors' processes and requirements.
**Main responsibilities**:
- Reviews and provides input in the development and improvement of the Company's Quality Management System (QMS) and controlled documents, pertaining to clinical operations.
Drafts clinical quality documents
- Engages in the interpretation and consultation on regulations, guidelines, and standards
- Ensures clinical trials/studies compliance with GCP, protocols, local and international legislation, Company and Sponsor SOPs, Policies and Guidelines
- Delivers quality related training sessions to all staff
- Conducts clinical suppliers' assessment and performance monitoring
- Conducts clinical trial specific documents' audits, as well as on-site and data management audits, as requested
- Conducts quality check/audit of TMF documents (both paper and electronic), as requested
- Performs regular checks to ensure clinical trial / study specific plans are executed
- Produces clinical trial/study specific quality metrics to allow executive and operational insights into study teams' and Sites' performance
- In collaboration with the Quality Maintenance Manager (QMM) and the Quality Director (QD), ensures deviations, non-conformances and potential non-conformances are properly documented, addressed, and monitored for effectiveness, in compliance with the Company's and the Sponsor's related procedures, as applicable
- Ensures corrective and preventive appropriate action process to quality findings
- Develops periodic reports describing compliance / non-compliance trends, identifies areas of potential risk and presents to QD
- Engages in inspection readiness of Sites and operational staff
- Performs Quality Co-monitoring Visits
- Contributes to audits the Company receives from Clients and Competent Authorities
- Engages in clinical trial / study quality review and oversight meetings
**Job Requirements**:
- Bachelor in natural or health sciences or related field
- Master of Science in natural or health sciences or related field
- Certification of knowledge of clinical trials standards (e.g., ICH GCP etc.
)
- Certification of knowledge of quality assurance standards (e.g., ISO 9001, etc.)
(strong advantage)
- Previous Work Experience:
- Proven experience as a Clinical Quality Assurance Manager / Senior GCP auditor or 5-year minimum experience in quality for clinical trials in CROs and/or pharmaceutical companies
- Previous experience with GCP system audits, Site and documentation audits and/or regulatory inspections
- Certified as an Auditor according to the Italian CRO Decree
- Excellent command of spoken and written English
- Other languages considered an asset
- Great attention to detail and a result-driven approach
- Reliable and trustworthy
- Planning and organization skills
- Outstanding communication and interpersonal skills
- Problem-solving skills
- Good knowledge of MS Office and databases savvy
- Advanced numerical skills and understanding of data analysis / statistical methods
- Ability to deal adequately with stressful situations, flexible timelines and work pressure
- Team working skills
- Willingness to travel
Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.
Competitive remuneration package comes on top.

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