Job Description

A very exciting opportunity has arisen in the GI & Lymphoma Unit at the Royal Marsden Hospital for a Trial Manager. You will need to be experienced and confident with regulatory submission and approval processes, clinical trial costing being self- motivated, pro-active and well organised to work within this friendly team in a highly pressurised environment at the forefront of research of GI & Lymphoma research.



This post has been developed to support set up and management of Royal Marsden sponsored single and multicentre trials. Experience is required to enable you to take a key role in setting up trials as well as supporting the set-up of participating sites, data handling/monitoring and trial co-ordination. The successful candidate will also be expected to contribute to all aspects of clinical trials administration across our sponsored trials portfolio to ensure the continued smooth and efficient delivery of research through set-up, day to day management, close out and archiving.



Applicants should hold a first degree in a life science or health related subject and have an in depth understanding and at least three years' working experience of Good Clinical Practice, Data Protection and Research Governance. Excellent interpersonal skills are essential to work to the high standards across a variety of tasks with constant regard to all regulatory requirements and Trust Standard Operating Procedures.



The Trial Manager will coordinate multifunctional team(s) consisting of clinician(s), statistician(s), database programmer, data manager/clinical trial assistant to project manage one or more complex clinical trials throughout their lifecycle. This may include protocol development, study set-up (including regulatory approvals), ongoing study management, closeout and reporting for RM and RM/ICR Sponsored clinical trials that are run by RM-CTU. Working with the support of the Senior Trial Managers and Unit Project Managers, the post holder will ensure that all clinical trials conducted to the relevant clinical trial regulations.



The role requires a clinical research professional who has extensive experience in clinical trials conduct ideally in different settings (Pharma, Academic) and familiarity with the regulatory environment surrounding clinical trials and the implementation of a quality management system as it pertains to clinical trial conduct.



The post holder will be based at Sutton within the Oak Cancer Centre, a new research and treatment facility, funded by The Royal Marsden Cancer Charity. Occasional travel to our Chelsea location and /or

other UK clinical trial sites will be required as the projects require.

There is potential for Hybrid working after training is completed



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.



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



Coordinate the set-up and conduct of clinical trials and clinical research projects.



Contribute to clinical trial design, protocol development and funding applications together with CI, statistician and other members of the team, under the supervision of Senior Trial Managers and Project Managers members.



Input into clinical trial protocols, prepare funding applications for new study proposals and prepare clinical trial budgets, under the supervision of the senior team members.



Contribute to preparation of essential clinical trials documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), Senior Trial Manager, Clinical Fellow etc



Contribute to preparation of trial documentation e.g. trial guidance notes, case report forms (CRFs), monitoring plans, in collaboration with relevant members of the Trial Management team including the CI, clinical fellow (where relevant) Clinical Trial Database Programmer (CTDP) and Statistician.



Contribute to preparation and submission of applications for ethics, regulatory, Sponsor, and other approvals that may be required in order to conduct the clinical trial.



Ensure all the required approvals and agreements are in place before the trial opens to recruitment.



Ensure clinical supplies or equipment are available and distributed appropriately



Set-up trial specific procedures including monitoring plans in accordance with RM (in it's capacity as Sponsor) SOPs to ensure the efficient management of the trial



Set-up up electronic Trial Master File and support research sites in the setup and maintenance of electronic Investigator Site Files.



Coordinate set-up of trial oversight committees and charters in collaboration with CI, statistician and other members of the team for Sponsored studies.



Plan and perform site initiation visits ensuring sites have all applicable documentation in place and that principal investigators and site staff understand the protocol and their responsibilities

within the trial.