Trial Manager

Job overview

An excellent opportunity has arisen at The Royal Marsden Hospital to work within the International Centre for Recurrent Head and Neck Cancer (IReC) as a Clinical Trial Manager.

With previous clinical research experience, you will work within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP. The successful applicant should have a flexible approach to their duties and the ability to work both as part of the team as well as independently. In addition you will have excellent communication, administrative and IT skills and be supportive and open to new initiatives.

As we often have many applicants for jobs at The Royal Marsden NHS Foundation Trust, we regret that we will only be able to contact those applicants who are short-listed for interview. Therefore if you have not heard from us within 2 weeks of the closing date, then please assume you have not been short-listed for interview on this particular occasion.

All applicants will be contacted by email via NHS jobs. Applicants are advised to check their email accounts, including their "junk" folders regularly and to ensure that email filters are set to allow NHS jobs emails. Please note that this is a fixed-term maternity cover role running until January 2028.

The position offers flexible working arrangements, including remote work and on-site presence across The Royal Marsden’s two sites: Chelsea, London and Sutton, Surrey.

Main duties of the job

• Contribute to the IReC development and strategy, including review of SOPs, policies and processes.
• Under the direction of the IReC network operations manager to lead implementation of systems within the Unit to ensure all Clinical Trials are conducted in accordance with all regulatory internal requirements including: o Medicines for Human Use (Clinical Trials) Regulations o Research Governance Framework for Health and Social Care o Human Tissue Act
• o Research and Development Policies and SOPs
• To be the main point of contact for the clinical R&D Office for set up and management of an assigned portfolio of clinical trials.
• Assist in preparation for audits and regulatory Inspections.
• To establish and maintain good channels of communication within the clinical research team, with other departments within the Trust and with other relevant organisations including non-commercial bodies and funders.

Detailed job description and main responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification:

• Contribute to clinical trial design, protocol development and funding applications together with Chief Investigator (CI), statistician and other members of the team.
• Preparation of and continual update of 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.
• To 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.
• To 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.