Job summary
The BRC has a vital role in championing change and improvement in cancer care through research and innovation, education and leading-edge practice. We are incredibly proud of our international reputation for pushing the boundaries and for our ground-breaking work ensuring our patients receive the very best and latest in cancer treatment and care.
This is a pivotal role and you will play a dual function. Primarily you will be part of a world class team of researchers delivering a prestigious, multi-million-pound, programme of National Institute for Health Research funded research work over the next 6 years. This involves a collaboration between The Royal Marsden, and almost a dozen partners across the UK. This programme has the ambitious aim of revolutionising the head and neck cancer pathway through the development and testing of a risk assessment tool delivered by way of a bespoke digital platform. In addition, you will also support clinical academics across the BRC at ICR and the Marsden in their preparations of high-quality research funding applications.
Main duties of the job
- The primary function of this role is to take responsibility for the smooth management and day to day administrate processes with respect to the delivery of an NIHR programme of research focussed on the development and evaluation of a risk assessment tool delivered by way of a digital platform. You will ensure the timely progression and co-ordination of a suite of projects against pre-defined financial and project milestones. The postholder will:
- Provide effective administrative and office service support to the Programme Research Team and contribute to the supervision and training of junior staff as necessary.
- Provide governance and support processes to assure RM of appropriate oversight, clear delegation of responsibility and effective lines of communication for the programme. This will include ensuring that all applicable clinical trials are conducted and managed in accordance with Good Clinical Practice and Trust SOPs.
- As a key member Keep accurate records, maintain study documentation, and input data into study specific database.
- Support the management of the programme against contracted milestones.
- Manage the finances and budget of the programme, ensuring expenditure matches pre-defined planned budget.
- Lead on the development of effective communication strategies for stakeholders.
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 and learning and development opportunities. 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 more information, please refer to the job description and person specification.
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/Translational Research 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 trial 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 Sponsor, 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.
Job description
Job responsibilities
For more information, please refer to the job description and person specification.
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/Translational Research 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 trial 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 Sponsor, 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.
Person Specification
Education/Qualifications
Essential
- Recent GCP training
- Life Sciences (or equivalent) degree or relevant experience
Desirable
- Master's or other higher-level degree
Experience
Essential
- Significant experience of working in a clinical trial setting
- Detailed understanding and experience of clinical trials, UK Clinical trial regulations, GCP and regulatory framework Experience of trial finances including costing for academic and commercial studies;
Desirable
- Previous experience managing drug (CTIMP) trials
- Personnel leadership and management experience
Skills, Abilities & Knowledge
Essential
- Excellent ability to manage complex projects involving multiple stakeholders
- 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 financial planning and management
Other Requirements
Essential
- Able to work on both sites and to be flexible to meet the needs of the role
Desirable
- Willingness to travel within the UK and occasionally overseas to attend meetings and conferences
Person Specification
Education/Qualifications
Essential
- Recent GCP training
- Life Sciences (or equivalent) degree or relevant experience
Desirable
- Master's or other higher-level degree
Experience
Essential
- Significant experience of working in a clinical trial setting
- Detailed understanding and experience of clinical trials, UK Clinical trial regulations, GCP and regulatory framework Experience of trial finances including costing for academic and commercial studies;
Desirable
- Previous experience managing drug (CTIMP) trials
- Personnel leadership and management experience
Skills, Abilities & Knowledge
Essential
- Excellent ability to manage complex projects involving multiple stakeholders
- 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 financial planning and management
Other Requirements
Essential
- Able to work on both sites and to be flexible to meet the needs of the role
Desirable
- Willingness to travel within the UK and occasionally overseas to attend meetings and conferences
Additional information
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).
