Description
An excellent opportunity has arisen at The Royal Marsden Hospital to work within the Sarcoma Research Team as a Senior Trial Manager.
This is a pivotal role and you will be part of a multidisciplinary team including experienced medical and nursing staff, managing an exciting range of clinical research studies.
You will have prior clinical trial management experience and be educated to degree level, working within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP.
Job Responsibilities:
- Contribute to clinical trial design, protocol development and funding applications together with Chief Investigator (CI), statistician and other members of the team.
- Prepare and continually update essential trial documentation in collaboration with CI, other members of the team, other departments at the Royal Marsden and other organisations as applicable.
- Complete and submit initial applications and amendments to internal Sponsor committee (CCR), REC and MHRA and other organisations as required for the clinical trial.
- Be the main point of contact for participating sites in multi-centre studies ensuring appropriate assessment of site feasibility for trial participation, planning site initiation visits and ensure sites have all applicable documentation in place.
- Have oversight of clinical trial activity and conduct of designated clinical trials.
- Manage systems for tracking trial conduct, such as ensuring recruitment and data entry targets are met and checking stock of IMP at sites.
- Coordinate supply and provision of any clinical trial equipment or supplies and ensure these are available as required.
- Contribute to design and validation of the database for each study, working with the statisticians and programmers.
- Ensure that Trial Master File (TMF) and Investigator Site Files (ISF) are correctly set-up and maintained.
- Coordinate set-up and running of trial oversight committees and regular meetings to plan and manage the studies, including preparing the agenda and meeting papers and writing minutes.
- Ensure that processes for receiving and processing Serious Adverse Event (SAE) and SUSAR reports are correctly followed to the required timelines.
- Ensure trial specific monitoring plans are created and adhered to, working with the statisticians and monitoring team.
- Plan and perform site initiation visits, and other monitoring visits as required.
- Contribute to preparation and submission of safety reports, progress reports, manuscripts, abstracts and posters.
Person Specification:
- Education/Qualifications: Life Sciences (or equivalent) degree or relevant experience. Recent GCP training.
- Experience: Significant experience of working in a clinical trial setting. Detailed understanding and experience of clinical trials, UK Clinical trial regulations, GCP and regulatory framework.
- Skills, Abilities & Knowledge: Advanced organisational skills and ability to manage multiple projects at various stages of development and organisation. Excellent communication skills and ability to facilitate collaborative working relationships.