Job summary
The Royal Marsden has a vital role in championing change and improvement in cancer care through research and innovation, education and leading-edge practice. The Urology Clinical Trials Research Unit focuses on research delivery for patients primarily with prostate and bladder cancers. As Senior Trial Manager, you will also be responsible for the development and management of our sponsored portfolio, where RM are acting as sponsor.
The Senior Trial Manager role is a pivotal role, mostly focusing on the set-up and management of RM-sponsored trials, and supporting coordination and management of the hosted portfolio. Experience of trial management is essential, as well as excellent IT and organisational skills. You will be in close liaison with R&D, Chief Investigators and sponsor teams, monitors and auditors, and external pharmaceutical and CRO companies, with a shared goal of ensuring that trials are successfully run and in compliance, with good quality data produced.
The job is based at our Chelsea site, with remote working permitted.
Main duties of the job
The Urology Clinical Trials Research Unit primarily focuses on research delivery for patients with prostate and bladder cancers, and some other urological cancers. As Senior Trial Manager, you will also be responsible for the development and management of our sponsored portfolio, where RM are acting as sponsor.
- To take responsibility for ensuring all clinical trials (primarily hosted with external sponsors) within the urology clinical trials (London) research unit are set-up, conducted and managed in accordance with Good Clinical Practice, Trust SOPs and trial protocols.
- To manage and lead the administrative team of the urology clinical trials (London) research unit.
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:
- Provide trial coordination support across all uro-oncology studies, including RM sponsored studies as required.
- Provide line management support to the team of administrative staff.
- Help obtain quality data outputs from the uro-oncology research unit.
- Maintain oversight that data and queries are managed in accordance to the study contract.
- Identify training and development needs of staff in line with departmental and Trust Objectives and ensure all new staff receive core and departmental induction.
- Ensure performance issues are dealt with in an appropriate and timely manner and follow the Trust's Disciplinary or Poor Performance Procedures where formal action is necessary.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Provide trial coordination support across all uro-oncology studies, including RM sponsored studies as required.
- Provide line management support to the team of administrative staff.
- Help obtain quality data outputs from the uro-oncology research unit.
- Maintain oversight that data and queries are managed in accordance to the study contract.
- Identify training and development needs of staff in line with departmental and Trust Objectives and ensure all new staff receive core and departmental induction.
- Ensure performance issues are dealt with in an appropriate and timely manner and follow the Trust's Disciplinary or Poor Performance Procedures where formal action is necessary.
Person Specification
Education/Qualifications
Essential
- Life sciences (or equivalent) degree or relevant experience
- Recent GCP training
Desirable
- Higher Degree qualification (e.g. MSc)
- Project management qualification
Experience/Knowledge
Essential
- Experience of working in a clinical trials setting as a clinical trial coordinator / manager or equivalent
- Detailed knowledge of clinical trials, UK Clinical trial regulations, GCP and regulatory framework.
- Experience of setting up and managing clinical trials
- Experience of budget management in clinical trials setting.
- Experience of managing/supervising administrative staff
- Experience of data management, overseeing data quality and resolution of queries
- Experience of working in the field of oncology
Desirable
- Experience of working in an NHS / pharmaceutical setting
- Experience of sponsored clinical trial management including protocol development and regulatory submission
Skills/Abilities
Essential
- Ability to prioritise workload and work autonomously, and adjust own work in light of unexpected events or changing priorities
- Able to work effectively to deadlines under direction and on own initiative
- Excellent administrative and organisational skills, with excellent attention to detail
- Excellent IT skills including Microsoft Excel and Power point
- Excellent oral and written communication skills, for day-to-day duties as well as report writing and presentations
- Proven problem solving skills
- Excellent interpersonal & communication skills with the ability to deal effectively with a wide range of people
- Able to negotiate, acting in a tactful and confident manner
Desirable
- Experience of developing systems and processes to allow efficient management and conduct of clinical trials
Person Specification
Education/Qualifications
Essential
- Life sciences (or equivalent) degree or relevant experience
- Recent GCP training
Desirable
- Higher Degree qualification (e.g. MSc)
- Project management qualification
Experience/Knowledge
Essential
- Experience of working in a clinical trials setting as a clinical trial coordinator / manager or equivalent
- Detailed knowledge of clinical trials, UK Clinical trial regulations, GCP and regulatory framework.
- Experience of setting up and managing clinical trials
- Experience of budget management in clinical trials setting.
- Experience of managing/supervising administrative staff
- Experience of data management, overseeing data quality and resolution of queries
- Experience of working in the field of oncology
Desirable
- Experience of working in an NHS / pharmaceutical setting
- Experience of sponsored clinical trial management including protocol development and regulatory submission
Skills/Abilities
Essential
- Ability to prioritise workload and work autonomously, and adjust own work in light of unexpected events or changing priorities
- Able to work effectively to deadlines under direction and on own initiative
- Excellent administrative and organisational skills, with excellent attention to detail
- Excellent IT skills including Microsoft Excel and Power point
- Excellent oral and written communication skills, for day-to-day duties as well as report writing and presentations
- Proven problem solving skills
- Excellent interpersonal & communication skills with the ability to deal effectively with a wide range of people
- Able to negotiate, acting in a tactful and confident manner
Desirable
- Experience of developing systems and processes to allow efficient management and conduct of clinical trials
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.
