Global Clinical Project Manager
CK Clinical are recruiting for a Clinical Project Manager to join a Global Biotechnology Company based in Hertfordshire on a permanent basis.
Our client is a highly innovative award winning biotechnology company focused in the development and commercialisation of gene therapies for the treatment of chronic diseases. You would be working with a highly committed team on the development of cutting edge therapies for the treatment of rare diseases.
The role is based at our client's site in Hertfordshire which is easily commutable from London, Essex, Bedfordshire, Cambridgeshire and Middlesex.
- Lead the planning and execution of global clinical studies from Phase I to IV in adherence GCP, FDA, ICH and EMA Guidelines.
- Ensure the management of budgets, milestones to ensure the associated budget meet the needs of the overall development plan agreed by the Project Team.
- Lead site selection and site qualification discussions with project team and CRO, ensuring appropriate selection of the CRO and manage/oversee and analysing CRO performance.
- Lead document writing and review for the protocol and amendments, Investigator brochure and Clinical Study Report. Additional medical writing tasks may involve ICF, CRF and associated guidelines, safety communications, DSUR and additional key documents.
- Engage and build relationships with clinical sites in North America (and potentially South America) and oversee CRO performance in US site set up, recruitment and patient follow up.
- Degree in a relevant discipline with 5+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at national and international level.
- Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development including.
- Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines.
- Strong scientific, operational and regulatory expertise. Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices.
- Ability to communicate effectively, including with therapy area experts and patient advocacy groups.
- Highly organised and able to plan, prioritise and manage time efficiently.
Entitlement to work in the UK is essential. For more information please contact Sam Whyley-Smith on 01438 870022 or email on email@example.com. Please quote reference 47647 in all correspondence.