This site uses optional cookies which are currently not set, but will be if you visit another page. Find out more about the cookies we use

Clinical Trial and Quality Management Administrator - F2G Ltd

Posted: 21 December 2017

Closing: 19 January 2018


F2G Ltd is a Manchester based Biotech company with research and development activities within the antifungal therapeutic area. The company is developing novel drug candidates and is in clinical trials with a lead candidate.

We are looking to recruit an individual with experience in a clinical trial and/or quality management administrative function with a sound knowledge of and familiarity with clinical trial operations, pharmaceutical industry quality systems and document management processes. This might include experience with clinical Trial Master Files, wider documentation to support the development of a product and/or Quality Management System document management.

Responsibilities:

1. Contribute to clinical study start-up, execution, close-out and reporting
2. Collect, review and track regulatory and other relevant documents. Interface 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)
3. Initiate and lead the set-up of the sponsor oversight file for the Trial Master File (TMF) including tracking of documents. Maintain and close the TMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance
4. Initiate and maintain production life cycle of documents, ensuring template and version compliance ( such as IB, IMPD etc)
5. Help format and collate documents, e.g. the administrative appendices for the CSR
6. Provide input into non-drug project work including training activities and development of procedures as needed
7. Set-up, populate and accurately maintain information in appropriate tracking tools
8. Manage and contribute to coordination and tracking of study materials and equipment as required
9. Support administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
10. Lead the practical arrangements and contribute 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
11. Prepare, contribute to and distribute presentation material for meetings, newsletters and web-site
12. Issuing and tracking of QMS documents to F2G employees, consultants and external parties.
13. Collation of comments and preparation of final drafts of QMS SOPs and other documents (as required) supporting regulatory activities.
14. Maintaining Change Control systems, including tracking logs and follow up activities.
15. Maintaining CAPA systems, including tracking logs and follow up activities.
16. Maintain filing of QMS documents, contracts, clinical and CMC agreements, supplier selection and evaluation forms, audit reports as appropriate

Please send your CV and covering letter stating current salary to:
Suzi Powell, Office Manager, F2G Ltd, Lankro Way, Eccles, Manchester M30 0LX
Email: spowell@f2g.com
Closing date: 19th January 2018