Clinical Project Manager
The Cancer Research UK & King's College London Cancer Prevention Trials Unit (CPTU) specialises in research to advance cancer prevention, early diagnosis and screening.
We perform research on efficacy, cost-effectiveness and technologies to improve existing and establish new screening programmes.
Our portfolio of both secondary (hospital) and primary (community) care trials includes:
- Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug repurposing
- Pragmatic trials of screening and diagnostic interventions
- Trials of behavioural interventions in cancer prevention and screening
- Trials of diagnostic/screening devices
About the role:
We are looking for an exceptional candidate to join the CPTU team to lead an exciting new early detection study in 2021.
You will be the clinical project manager for a NHS research study of a multi-cancer early detection test with GRAIL Bio UK Ltd, NHS England and NHS Improvement. Over 700,000 people across England will be invited to receive a novel CE-marked, blood test for the presence of over 50 cancers. You will be responsible for set-up and delivery of the project in close coordination with GRAIL and key stakeholders.
You will have a strong interest and knowledge of health innovation and health service delivery, and experience of fostering strategic relationships with research and health care organisations, and with public bodies. You will be an effective communicator who is adaptive to their audience, with an intrinsic interest in improving the health and well-being of communities through translational research and evidence-based innovation.
- utilise past experience in clinical project management to ensure the project is delivered on time and to budget
- as the main study focal point, establish and maintain key strategic relationships with the study sponsor, networks of clinicians, researchers and health service managers for effective roll-out of the trial
- lead a team of trial managers, data managers and administrators to ensure GCP and data protection compliance and to manage the responsibilities of commercial trials in compliance with relevant regulations and sponsor requirements
- set-up and manage the trial and actively contribute to the research planning and development in partnership with the Chief Investigator(s), sponsor, clinicians, executive and steering groups and study teams
- be the key liaison with all university departments, relevant ethics and R&D committees, funding bodies, and sponsor monitors
- provide support to local research sites, and develop new initiatives to ensure they are working to the highest standards and to monitor and report on the progress of trials to the Sponsor
- set overall standards for trial management by overseeing and approving the writing and distribution of written procedures
- develop and implement a communications package to engage participants, clinicians, health service managers and scientists in the ongoing trial
- undertake financial planning, management and reporting on project implementation
You will line manage a large team of staff including trials managers and data management staff. You will report to and be supervised by Dr Michelle Sleeth, Head of Operations of CPTU. Your seniority will offer the potential to coach and line manage other study coordinators and data managers and you will be required to develop strong working relationships with other trial coordinators across King's. We value your professional growth and you will have opportunities to attend conferences and training.
This post is currently home-working in response to COVID-19. The post holder will also be required to provide a weekend on-call service or fully work on a weekend day on a rota basis during busy periods. Extra hours will be paid as overtime in addition to the stated salary (Saturdays- time and a half (base rate excluding London Allowance), Sundays, bank and public holidays, closure days - double time (base rate excluding London Allowance). For this reason, the postholder must be self-motivated and be able to work independently.
This is a full-time 35 hours per week post.
This is a fixed term contract until December 2025.
- Devise and develop research strategy for delivery of high-profile, national research study
- Develop and maintain key strategic relationships with programme partners
- Line manage a large team of trial staff, ensuring systems and processes are effectively implemented to ensure the Chief Investigator is supported in conducting trials to required standards
- Independently provide trial management advice at the planning and funding application stages of new projects and ensure a consistent data management service is provided
- Set standards and supervise the monitoring of trial sites, to problem solve and review source data
- Ensure trial timelines are monitored and kept to schedule
- Develop an in-depth knowledge of the trial protocols, to be able to respond to queries
- Monitor and coordinate intervention supplies and intervention compliance
- Assist in the education and training of trials active staff. This training to include GCP guidelines, relevant legislation and the research governance framework and to be delivered to staff conducting commercial and non-commercial trials
- Prepare and supervise the preparation of submissions for ethics and regulatory approval, annual progress reports, contribute to reports to funders and manage communications with the Sponsor organisation
- Ensure appropriate contractual arrangements are in place and documents held on file
- Maintain knowledge and be responsible for advising others on Good Clinical Practice standards and Regulatory framework 2004
- Plan expenditure against multiple trial budgets and negotiate with suppliers under the guidance and approval of the study chief investigator
- Produce promotional material and dissemination plans
- Develop trial risk assessments and trial monitoring plans
- Develop written procedures for trial processes where appropriate
- Contribute to the development of training initiatives
- Any other duties appropriate to the grade as directed by the supervisors
- Delegate any tasks as appropriate
Skills, knowledge, and experience
- Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse)
- Excellent knowledge of Good Clinical Practice, Data Protection Act and the regulations governing the research use of in vitro diagnostics
- Experience of managing a large multicentre trial in NHS services, from inception through to completion
- Strong delegation skills and ability to develop and implement robust procedures to support individuals within the full capacity of their role
- Understanding of NHS strategic goals, research structure and organisation
- Ability to produce appropriate trial management written procedures and implement them and show attention to detail and high standards of accuracy in all aspects of work
- Experience in providing supervision / line management to multidisciplinary teams/staff and managing varied workloads
- Experience of financial planning and implementation
- Experience of explaining complex ideas in an appropriate format for academic and non-academic groups
- Experience of working independently, making independent decisions and working to and meeting firm deadlines
- Excellent verbal and written communication skills, particularly in the context of scientific writing, reports and good telephone manner e.g. ability to persuade and deliver information effectively through presentations
- Willing to travel within the UK, flexibly to accommodate the needs of the project
- Experience of primary care research and working with commercial sponsors
- Experience of using centralised NHS datasets for research
- Experience of oncology research
- Formal qualification in clinical trials (or working towards one) or post graduate qualification in clinical trials or relevant field
- Knowledge of electronic data capture systems for clinical trials
This post is based at Guy's Hospital, London Bridge and GRAIL's office in central London but will be remote working until further notice.
This post is subject to Occupational Health clearance.