Clinical Study Manager
Jim Gleeson is recruiting for a Clinical Study Manager to join an innovative biotech with a very promising lead candidate approaching Phase III clinical research. This role can be fully home based in the UK.
As Clinical Study Manager you will be responsible for the planning, management and completion of clinical studies in full compliance with company strategies, ICH-GCP and other relevant regulations.
Key duties will include:
- Working closely with Head of Clinical Operations and Chief Medical Officer to project manage outsourced clinical studies to support registration of the company's products
- Leadership of the internal study team and external vendors, ensuring that studies are completed to the highest quality standards and to agreed timelines and budgets
- Due diligence of CROs and other third party vendors
- Preparation of protocols, informed consent forms, procedures manual and other clinical study documents
- Ensuring inspection readiness at all times
As Clinical Study Manager you will require the following:
- A life science degree, ideally an MSc
- Extensive international clinical trial management experience, ideally for haematology or oncology research
- Experience of the selection and management of Contract Research Organisations, hospitals and study sites globally
- An in-depth knowledge of ICH-GCP
- Willingness to travel internationally, 20 - 30%
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or via email on firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47390 in all correspondence.