Job overview
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.
Main duties of the job
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
Detailed job description and main responsibilities
1. Coordinate the set-up and conduct of clinical trials and clinical research projects.
2. 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.
3. 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.
4. 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
5. 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.
6. 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.
7. Ensure all the required approvals and agreements are in place before the trial opens to recruitment.
8. Ensure clinical supplies or equipment are available and distributed appropriately
9. 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
10. Set-up up electronic Trial Master File and support research sites in the setup and maintenance of electronic Investigator Site Files.
11. Coordinate set-up of trial oversight committees and charters in collaboration with CI, statistician and other members of the team for Sponsored studies.
12. 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.
Person specification
Education/Qualifications
Essential criteria
13. Educated to degree level or equivalent experience
Desirable criteria
14. Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences.
15. Project Management qualification (eg PRINCE 2)
Experience
Essential criteria
16. Experience of working to UK clinical trials regulations
17. Previous clinical trial experience – ideally with protocol development, reporting, and archiving
18. Experience of working in a clinical research environment within NHS, University or pharmaceutical industry
19. Experience of preparing REC submissions
20. Experience of working across organisational boundaries with multidisciplinary teams
21. Experience of communicating effectively with all levels of staff - written and verbal
22. Clear understanding of and interest in cancer research
23. Proven problem solving skills.
24. Excellent presentation skills
Desirable criteria
25. Experience of developing and implementing new SOPs and processes
26. Experience of preparing REC, HRA, MHRA, IRMER and other submissions
27. Experience working on complex clinical trials with Investigational Medicinal Product
28. Experience of regulatory inspections
Skills/Knowledge
Essential criteria
29. Knowledge of UK Clinical trial regulations, GCP and regulatory framework
30. Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up stage
31. Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trials regulations
32. Knowledge of clinical trial design issues in conducting oncology studies
33. Understanding of the clinical trials approval process to conduct clinical research in the UK
34. Proficient in the using PC based Windows and Microsoft Office
Desirable criteria
35. Knowledge of database set-up and data management processes and procedures necessary to conduct clinical trials
36. Knowledge of Clinical trial methodology and /or statistical issues as they pertain to clinical trials
37. Knowledge of developing budgets for clinical trials including AcORD process
38. Knowledge of Visio
Other Requirements
Essential criteria
39. Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
40. Maintain a positive and enthusiastic attitude towards tasks and their goals
41. Ability to work well within a multi-disciplinary team environment in an effective and supportive way
42. Able to work under pressure, methodical in approach, with effective problemsolving ability
43. Ability to work effectively to tight deadlines under direction and on own initiative.
44. A high level of accuracy and attention to detail
45. Flexible attitude and capable of dealing with changing working conditions
Desirable criteria
46. Ability to negotiate, acting in a tactful and confident manner to achieve the desired results
The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.
As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.
Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.
Flu Vaccination – What We Expect of our Staff
At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.
The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.
Employer certification / accreditation badges
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