Job summary
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 hosted commercial, non-commercial and Royal Marsden sponsored 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 hosted 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
- 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.
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 description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Liaise closely with the CI, RM-CTU, CTDP, Statistician and other key members of the study team (i.e. clinical fellow) to ensure on-going clinical, scientific and operational oversight under the guidance of the Senior Trial Managers and Project Managers.
- Be a point of contact for participating sites, sponsor(s), funder(s), pharmaceutical partners, regulatory authorities and the trial oversight committees.
- Contribute to the day-to-day conduct of the study at participating sites, providing support and advice and addressing any logistical issues as they arise
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Liaise closely with the CI, RM-CTU, CTDP, Statistician and other key members of the study team (i.e. clinical fellow) to ensure on-going clinical, scientific and operational oversight under the guidance of the Senior Trial Managers and Project Managers.
- Be a point of contact for participating sites, sponsor(s), funder(s), pharmaceutical partners, regulatory authorities and the trial oversight committees.
- Contribute to the day-to-day conduct of the study at participating sites, providing support and advice and addressing any logistical issues as they arise
Person Specification
Education/Qualifications
Essential
- Educated to degree level or equivalent experience
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences
- Project Management qualification (eg PRINCE 2)
Experience
Essential
- Experience of working to UK clinical trials regulations
- Previous clinical trial experience - ideally with protocol development, reporting, and archiving
- Experience of working in a clinical research environment within NHS, University or pharmaceutical industry
- Experience of preparing REC submissions
- Experience of working across organisational boundaries with multidisciplinary teams
- Experience of communicating effectively with all levels of staff - written and verbal
- Clear understanding of and interest in cancer research
- Proven problem solving skills
- Excellent presentation skills
Desirable
- Experience of developing and implementing new SOPs and processes
- Experience of preparing REC, HRA, MHRA, IRMER and other submissions
- Experience working on complex clinical trials with Investigational Medicinal Product
- Experience of regulatory inspections
Skills/Knowledge
Essential
- Knowledge of UK Clinical trial regulations, GCP and regulatory framework
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up stage
- Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trials regulations
- Knowledge of clinical trial design issues in conducting oncology studies
- Understanding of the clinical trials approval process to conduct clinical research in the UK
- Proficient in the using PC based Windows and Microsoft Office
Desirable
- Knowledge of database set-up and data management processes and procedures necessary to conduct clinical trials
- Knowledge of Clinical trial methodology and /or statistical issues as they pertain to clinical trials
- Knowledge of developing budgets for clinical trials including AcORD process
- Knowledge of Visio
Other Requirements
Essential
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way.
- Able to work under pressure, methodical in approach, with effective problemsolving ability
- Ability to work effectively to tight deadlines under direction and on own initiative
- A high level of accuracy and attention to detail
Desirable
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results
Person Specification
Education/Qualifications
Essential
- Educated to degree level or equivalent experience
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences
- Project Management qualification (eg PRINCE 2)
Experience
Essential
- Experience of working to UK clinical trials regulations
- Previous clinical trial experience - ideally with protocol development, reporting, and archiving
- Experience of working in a clinical research environment within NHS, University or pharmaceutical industry
- Experience of preparing REC submissions
- Experience of working across organisational boundaries with multidisciplinary teams
- Experience of communicating effectively with all levels of staff - written and verbal
- Clear understanding of and interest in cancer research
- Proven problem solving skills
- Excellent presentation skills
Desirable
- Experience of developing and implementing new SOPs and processes
- Experience of preparing REC, HRA, MHRA, IRMER and other submissions
- Experience working on complex clinical trials with Investigational Medicinal Product
- Experience of regulatory inspections
Skills/Knowledge
Essential
- Knowledge of UK Clinical trial regulations, GCP and regulatory framework
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up stage
- Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trials regulations
- Knowledge of clinical trial design issues in conducting oncology studies
- Understanding of the clinical trials approval process to conduct clinical research in the UK
- Proficient in the using PC based Windows and Microsoft Office
Desirable
- Knowledge of database set-up and data management processes and procedures necessary to conduct clinical trials
- Knowledge of Clinical trial methodology and /or statistical issues as they pertain to clinical trials
- Knowledge of developing budgets for clinical trials including AcORD process
- Knowledge of Visio
Other Requirements
Essential
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way.
- Able to work under pressure, methodical in approach, with effective problemsolving ability
- Ability to work effectively to tight deadlines under direction and on own initiative
- A high level of accuracy and attention to detail
Desirable
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results
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.
