Job summary
An exciting opportunity has arisen to join The Royal Marsden as a Senior Trial Manager working cross tumour teams. This is an ideal opportunity for an experienced Trial Manager looking to take their career to the next level. You will join a team of experienced trial professionals and world class clinicians and be a part of ground-breaking research into cancer treatments.
Candidates must have significant relevant experience of setting up hosted commercial clinical trials. You will be expected to set up Trust high priority Cancer Vaccines trials and will be overseeing the portfolio across multiple groups. 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.
Hybrid working in office/at home is supported in this team.
For further information and informal queries please contact:
Sajjida.jaffer@rmh.nhs.uk
Main duties of the job
o Responsible for coordinating all cancer vaccine trials activities required for the effective set-up and running of those trials across multiple tumour groups.o Undertake the project management for the studies, working with other departments within the Royal Marsden Hospital as well as sponsors.o Support and actively engage in ensuring cancer vaccine trials are set up as efficiently as possibleo Support and actively streamline set up and delivery of cancer vaccine trials across multiple tumour groups.o Providing support to Cellular Therapies Clinical Research Operations for Cellular Therapies Clinical Trials Porfolio within the Trusto 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 Day-care 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 the development and strategy, including review of Clinical Research SOPs, policies and processes.
- 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 in particular cancer vaccines.
- Assist in preparation for GCP 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
- The Senior Trial Manager will, together with the Operations Manager will manage cancer vaccines portfolio working with clinicians and support services.
- Preparation of and continual update of essential trial documentation in collaboration with other members of the team, other departments at the Royal Marsden.
- Support with preparation of documentation along with other members of the research team where Royal Marsden Hospital is the lead site.
- To be the main point of contact with the Sponsor in ensuring appropriate assessment of site feasibility for trial participation, planning site initiation visits for cancer vaccine trials.
- To have oversight of cancer vaccines and cellular therapy clinical trial activity across multiple tumour groups.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Contribute to the development and strategy, including review of Clinical Research SOPs, policies and processes.
- 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 in particular cancer vaccines.
- Assist in preparation for GCP 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
- The Senior Trial Manager will, together with the Operations Manager will manage cancer vaccines portfolio working with clinicians and support services.
- Preparation of and continual update of essential trial documentation in collaboration with other members of the team, other departments at the Royal Marsden.
- Support with preparation of documentation along with other members of the research team where Royal Marsden Hospital is the lead site.
- To be the main point of contact with the Sponsor in ensuring appropriate assessment of site feasibility for trial participation, planning site initiation visits for cancer vaccine trials.
- To have oversight of cancer vaccines and cellular therapy clinical trial activity across multiple tumour groups.
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
- Previous experience setting up hosted commercial trials
Desirable
- Experience of trial finances including costing for academic and commercial studies
- 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
- Previous experience setting up hosted commercial trials
Desirable
- Experience of trial finances including costing for academic and commercial studies
- 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.
