Job description
 
About Us:  
 
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 re-purposing 
•        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 enthusiastic Deputy Clinical Project Manager/Trial Manager to join the CPTU team to for the ground-breaking NHS-Galleri trial. 
You will be the Deputy 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 support the successful delivery of the project in close coordination with internal and external stakeholders. 
You will have a strong interest and knowledge of clinical trials research, and experience of delivering relevant research projects. You will have excellent organisational and planning skills with an intrinsic interest in improving the health and well-being of communities through translational research and evidence-based innovation. 
 
You will: 
•        utilise past experience in trials management/clinical project management to help lead the wider project team in delivering the project according to milestones 
•        support key strategic relationships with the study sponsor, networks of clinicians, researchers and health service managers for effective roll-out of the trial 
•        lead members of the NHS-Galleri team to ensure GCP and data protection compliance and to manage the responsibilities of commercial trials in compliance with relevant regulations and sponsor requirements 
•        support ongoing management of 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 
•        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  
•        support the delivery of the communications package to engage participants, clinicians, health service managers and scientists in the ongoing trial 
•        ensure that the eTMF and QMS is maintained to relevant standards 
•        deputise for the Clinical Project Manager as required 
 
You will line manage within the NHS-Galleri operational team.  You will report to and be supervised by Simranjit Mehta, NHS-Galleri Clinical Project Manager.  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.   
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 post will be offered on an a fixed-term contract until end of June 2023 
This is a full-time  post - 100% full time equivalent

  
Key Responsibilities 
•           Act as a central point of communication for the trial for the research team, recruiting sites and all other relevant bodies. 
•           Develop, implement and update the e-Trial Master File and coordinate the distribution of investigator files and version control relevant study document 
•         Support the delivery of the communications package to engage participants, clinicians, health service managers and scientists in the ongoing trial 
•           Plan and monitor recruitment of participants into the trial, identifying barriers and implementing strategies to improve recruitment   
•           In conjunction with the trial statistician and data coordinator, monitor data quality and assist with data cleaning, to achieve an accurate and complete dataset 
•           Schedule and administer operational and trial oversight groups as required 
•           Contribute to the developments of amendments 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 
•           Responsible for the completion, management and development of all relevant procedures for the conduct of the protocol and ongoing management of the study quality management system 
•           Use initiative and creativity to resolve issues that might arise and identify issues that require onward reporting to the Chief Investigator and Sponsor 
•           Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and quality standards and that appropriate records and audit trails are maintained  
•           Monitor trial sites to problem solve and review source data (where appropriate) or provide training 
•           Where appropriate, manage reported SAEs, checking for missing or inconsistent data and querying sites.  Ensure reports are reviewed appropriately and sent to any key parties. Ensure all events are followed up to resolution 
•           Work closely with sites to ensure timely data entry, cleaning and query resolution 
•           Ensure confidentiality on all matters and information obtained during the course of employment 
•         Deputise for the clinical project manager as applicable 
 
 
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.  
 

Skills, knowledge, and experience 

Essential criteria  
 
1.        Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse) 
2.        An understanding of ICH/GCP guidelines and other applicable regulations, including the regulations governing the research use of in vitro diagnostics 
3.        Proven experience of trials management including recruitment oversight, maintenance of regulatory approvals, site liaison, data management and safety reporting.  
4.        Excellent IT skills including working with complex databases and management information systems 
5.        Understanding of medical terminology, either through study or working in a medical environment 
6.        Knowledge of project management methodology and commitment to acquire complete project management skills i.e. large-scale health or public sector-related projects with defined targets and performance milestones 
7.        The ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them 
8.        Ability to work on own initiative and prioritise own schedule without supervision  
9.        Excellent verbal and written communication skills, particularly in the context of scientific writing, reports and good telephone manner. Ability to persuade and deliver information effectively through presentations 
10.    Willing to travel with the UK flexibly to accommodate the needs of the project 
11.    Ability to show attention to detail and high standards of accuracy in all aspects of work 
12. Previous experience of line management or supervising other staff 
 
Desirable criteria 
 
1.        Experience in trials of cancer screening/early detection or large scale health projects 
2.        Formal qualification in clinical trials (or working towards one) and/or post graduate qualification with a research methodology element 
3.        Experience of working at all stages of the trial life-cycle (set up to close out) 
 
 
Further information
 
Please contact michelle.sleeth@kcl.ac.uk  
This post is subject to Disclosure and Barring Service and Occupational Health clearance.