The Role:To be accountable for CMC site transfer submissions for country acceptability in terms of content, according to local regulations and requirements for assigned markets....
Clinical Trial and Quality Management Administrator
Excellent opportunity for an experienced TMF Specialist/QMS
Full-time, Permanent - office based in Manchester
Having recently partnered with a highly ambitious and rapidly growing biotech company I am delighted to support the search for Clinical Trial and Quality Management Administrator. This is probably the best moment to join our client and further develop experience within pharmaceutical industry.
Clinical Trial and QM Administrator will be responsible for:
- Contributing to clinical study start-up, execution, close-out and reporting
- Collecting, reviewing and tracking regulatory and other relevant documents. Interfacing with, Investigators, Strategic Partners, Site Management & Monitoring and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR)
- Initiating and leading the set-up of the sponsor oversight file for the Trial Master File (TMF) including tracking of documents. Maintaining and closing the TMF
- Initiating and maintaining production life cycle of documents, ensuring template and version compliance
- Providing input into non-drug project work including training activities and development of procedures as needed
- Setting-up, populating and accurately maintaining information in appropriate tracking tools
- Leading the practical arrangements and contributing to the preparation of internal and external meetings e.g. study team meetings, ISS review meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors
- Preparing, contributing to and distributing presentation material for meetings, newsletters and web-site
- Maintaining CAPA systems, including tracking logs and follow up activities.
- Maintain filing of QMS documents, contracts, clinical and CMC agreements, supplier selection and evaluation forms, audit reports as appropriate
- Previous experience in similar role within pharma industry
- Strong knowledge of clinical trial and/or quality management administrative function
- sound knowledge of and familiarity with clinical trial operations, pharmaceutical industry quality systems and document management processes
- Life science degree
- Eligibility to work and live in the UK
- Excellent verbal and written communication skills
HOW TO APPLY?
Click on the "apply" button below. Alternatively for immediate consideration contact Mariusz Stokowacki on +44 (0)203 096 4703 or email
SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of 'Creating Tomorrow's World'& helping patients world-wide.
Our team at SRG Clinical also cover roles in Clinical Operations (CPM, CRA etc.), Biometrics (Statistics, SAS programming, Data Management), Medical information, Medical Affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to call me at +44 (0)203 964 700.
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The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.