Clinical Study Manager
Jim Gleeson is recruiting for a (Senior) Clinical Study Manager to join a long established biotechnology company with a strong portfolio of immuno-oncology therapies in clinical development. The position will be based at their Oxfordshire offices, with the option of working from home for two days per week.
As (Senior) Clinical Study Manager you will work closely with clinical and development teams to ensure that clinical operations proceed to plan, hitting timeline and budgetary targets and in full compliance with ICH-GCP requirements and company SOPs.
Key duties will include:
- Maintenance of a strong understanding of the pipeline, product portfolio and business needs in order to best support project teams.- Lead vendor selection activities through the RFP and Proposals process and oversee successful vendors to ensure are performed in compliance with all requirements.
- Support the preparation of clinical study documents such as Investigator Brochures, Protocols and DSURs.
- Performing co-monitoring visits and building relationships with study site and CRO staff.
- Developing and controlling recruitment strategies.
- Proposal, development and implementation of improved processes and practices at study and department level, including the development, review and approval of SOPs and working instructions.
As (Senior) Clinical Study Manager you will require the following:
- Clinical operations experience gained with a biotechnology company environment.
- Experience of CRO selection and management.
- An oncology background would be highly advantageous.
- Strong project management skills.
For more information or to apply for this position, please contact Jim Gleeson on 01438 842973 or email email@example.com. 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 46512 in all correspondence.