Job summary
An exciting opportunity has arisen to join The Royal Marsden Clinical Trials Unit as a Trial Manager in the RM-CTU Breast team. This is an ideal opportunity for a Data Manager looking to progress in their career or a Trial Manager/Coordinator wishing to learn more about oncology drug trials from the sponsor perspective. You will join a team of experienced trial professionals, world class clinicians and scientists based in the Ralph Lauren Centre for Breast Cancer Research, and be a part of ground-breaking research into breast cancer treatments.
As a Trial Manager you will have responsibility for at least one clinical trial, including maintenance of Trial Master File and key study documentation, obtaining relevant ethical and regulatory approvals, safety reporting of adverse events, monitoring trial progress and facilitating meetings, and producing reports for various stakeholders. Some supervision of junior members of the team may be required.
Candidates must have prior relevant experience of working on clinical trials, either from within the NHS, industry, or academic sector. You will be expected to ensure high standards of practice in accordance with the principles of GCP. In addition, you will have excellent communication and organisational skills and the ability to work proactively and independently. Good time management skills and ability to prioritise competing workloads are required.
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
IMPORTANT NOTE: There is a limit of 25 applications for this vacancy. Vacancy may be closed once this limit is reached. Please therefore only apply if you meet all essential criteria for this position.
For further information, please refer to the job description and person specification
These responsibilities will be carried out under the guidance of lead project manager.
Service Delivery
Contribute to the RM-CTU development and strategy, including review of RM-CTU SOPs, policies and processes.
Under the direction of the Lead Project Manager to lead implementation of systems within the Unit to ensure all Clinical Trials are conducted in accordance with all regulatory internal requirements including:
- Medicines for Human Use (Clinical Trials) Regulations
- Research Governance Framework for Health and Social Care
- Human Tissue Act
- Research and Development Policies and SOPs
To be the main point of contact for the clinical R&D Office for set up and management of an assigned portfolio of clinical trials.
Assist in preparation for audits and regulatory Inspections.
To establish and maintain good channels of communication within the clinical research team, with other departments within the Trust and with other relevant organisations including non-commercial bodies and funders.
Clinical research management
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.
Job description
Job responsibilities
IMPORTANT NOTE: There is a limit of 25 applications for this vacancy. Vacancy may be closed once this limit is reached. Please therefore only apply if you meet all essential criteria for this position.
For further information, please refer to the job description and person specification
These responsibilities will be carried out under the guidance of lead project manager.
Service Delivery
Contribute to the RM-CTU development and strategy, including review of RM-CTU SOPs, policies and processes.
Under the direction of the Lead Project Manager to lead implementation of systems within the Unit to ensure all Clinical Trials are conducted in accordance with all regulatory internal requirements including:
- Medicines for Human Use (Clinical Trials) Regulations
- Research Governance Framework for Health and Social Care
- Human Tissue Act
- Research and Development Policies and SOPs
To be the main point of contact for the clinical R&D Office for set up and management of an assigned portfolio of clinical trials.
Assist in preparation for audits and regulatory Inspections.
To establish and maintain good channels of communication within the clinical research team, with other departments within the Trust and with other relevant organisations including non-commercial bodies and funders.
Clinical research management
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.
Person Specification
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
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
Other requirements
Essential
- Able to work on both sites and to be flexible to meet the needs of the role
Person Specification
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
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
Other requirements
Essential
- Able to work on both sites and to be flexible to meet the needs of the role
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
