Job summary
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 Careo 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.

About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.

At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.

At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.

Job 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.

Person Specification
Education/Qualifications
Essential

• Life Sciences (or equivalent) degree or relevant experience
• Recent GCP training

Desirable

• Masters' Degree or other higher-level degree

Experience
Essential

• Demonstrable /significant experience of working in a clinical trial setting
• Detailed understanding and experience of clinical trials, UK Clinical trial regulations, GCP and regulatory framework

Desirable

• Experience of trial finances including costing for academic and commercial studies
• Previous experience managing drug (CTIMP) trials

Skills, Abilities & Knowledge
Essential

• 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
• Able to work under pressure, methodical in approach, with effective problem-solving ability
• Competence in research orientated PC software including Microsoft Office packages

Desirable

• Knowledge of principles for quality management systems
• Knowledge of budget planning and management

Other Requirements
Essential

• Able to work on both sites and to be flexible to meet the needs of the role

Desirable

• Willingness to travel within UK and occasionally overseas to attend meetings and conferences

Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

We are an equal opportunities employer and welcome applications from all sections of the community.