Clinical Study Manager in Oxford
Jim Gleeson is recruiting for a Clinical Study Manager to join a very well funded biotechnology company in Oxford, initially to oversee studies in a portfolio of vaccine treatments for a number of therapeutic areas.
As Clinical Study Manager you will manage complex studies, some of which will be international. As the company is still small in numbers you will need to happy working in a fast-paced environment and turn your hand to a very wide variety of functions.
Key duties will include:
- Management of all aspects of allocated studies in accordance with internal SOPs, ICH GCP and all applicable laws and regulations.
- Selection and oversight of CROs, third party vendors and contract staff.
- Periodic co-monitoring with contract CRAs and CROs to ensure high quality monitoring and site management.
- Management of clinical trials supplies in conjunction with third party storage and distribution specialists.
- Development and maintenance of strong relationships with sites and KOLs.
As Clinical Study Manager you will require the following:
- A relevant life science degree.
- Industrially based, early phase clinical project management experience.
- Experience of development of protocols, Investigator Brochures and IMP Dossiers.
- Experience of the management of third party vendors.
- An in-depth knowledge of the entire clinical trial process, from first in man through to regulatory filing for marketing.
- An excellent knowledge of GCP requirements and current clinical trial legislation.
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or email 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 44494 in all correspondence.