Job summary
An opportunity has arisen at The Royal Marsden to work within the Haemato-Oncology Unit as a Trial Manager, providing governance and operational support for our complex Investigator-Initiated portfolio of studies.
This is a pivotal role, and you will be part of a team of qualified and skilled medical and nursing staff, taking part in an exciting range of clinical research studies as well as having a key role contributing to the development and expansion of this portfolio. Ideally with previous clinical research experience and NHS 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.
Based at our Sutton location with occasional travel to our Chelsea location and some remote working, 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..
Main duties of the job
- Responsible for coordinating all the activities required for the effective running of clinical trials and other studies in the portfolio.
- Undertake the project management for the studies, working with other departments within the Royal Marsden Hospital as well as sites, funders, external collaborators and contractors.
- Support and actively engage in the creation of the documentation required for each study, as well as any amendments to the study documentation and submissions or reporting to regulatory authorities.
- Take a leadership role within the team, supervising and supporting junior staff within the team.
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:
- 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.
Job description
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.
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
- Personnel leadership and management experience
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
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
- Personnel leadership and management experience
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
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.
