Consultant: Life Sciences Team
Salary: £38000 - £42000
Job Status: Permanent / Full Time
we are currently searching for an Associate Clinical Project Manager based in Surrey. The ideal candidate we would be looking for is someone who has been a healthcare professional with at least 6 years of clinical experience, or Science Graduate with 4 or more years’ experience as a Clinical Research Associate / Senior Clinical Research Associate, with a soundtrack record in managing clinical trial sites, Experience of oncology clinical trials and cancer therapies and Good knowledge of one (or more) European language an advantage
The primary responsibilities of this position include, but are not limited to, the following:
1. Assist Project Manager in day to day running of projects assigned.
2. Act together with the Project Manager as the routine liaison between Oncology and Sponsor representatives.
3. Assist Project Manager in reviewing protocol, amendments, Informed Consent Forms or co-ordinate these activities.
4. Assist Project Manager to Co-ordinate/develop/finalise study start up materials, e.g., SOP, draft CRFs, completion manual, compliance forms, study prompters/calendars, study operations manuals.
5. Co-ordinate/prepare project specific materials e.g., status reports, newsletters, templates, etc. Review site-visit reports.
6. Co-ordinate/conduct pre-qualification, initiation, routine monitoring and close-out visits.
7. Perform routine monitoring activities including site visits as required.
8. Assist Project Manager to organise Investigator/CRA Training Meetings. Prepare and deliver presentations for Investigator Meetings.
9. Serve as a mentor to project specific staff. Prepare and deliver staff training sessions. Organise and conduct CRA training and sign off visits.
10. Provide support to the Regulatory Affairs team in the preparation of Ethics Committee submissions in relevant countries.
11. Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
- Completion of Oncology training programme.
- Detailed knowledge of oncology study endpoints
- Detailed knowledge of ICH-GCP
- Demonstrated understanding of clinical databases
- Excellent interpersonal skills/strong leadership abilities
- Proven ability to demonstrate strong decision making and problems solving skills
- Strong time management skills and the proven ability to meet deadlines
- Strong communication skills: verbal/written
If you are interested in this please get in touch and send your CV