The Cancer Prevention Group (CPG) led by Professor Sasieni, seeks a maternity cover for the post of a Trial Manager. We are a dynamic group of research professionals specialising in research to advance cancer prevention, early diagnosis and screening. Within the CPG there is the Cancer Research UK & King's College London Cancer Prevention Trials Unit (CPTU) which performs research on efficacy, cost-effectiveness and technologies to improve existing and establish new screening programmes.
About the role
You will be part of a highly collaborative and inclusive team, working as a Trial Manager to lead and assist in the development, set-up and ongoing operational management of a variety of clinical studies in cancer screening and prevention. The role has a focus on HPV self-sampling studies in GP primary care, including the YouScreen study (https://www.bbc.co.uk/news/health-56168170), therefore, experience in studies in primary care or cervical screening will be advantageous.
You will have a strong interest and knowledge of clinical trials research, and experience of delivering relevant research projects. You will be a clear communicator, 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.
- Oversee the research studies on the CRUK CPG programme
- Facilitate the development of new research proposals
- Supporting the set-up activities of new studies
- Provide short-term support to projects, where required
- Work with key project stakeholders including the academic leads, to ensure the projects are delivered according to agreed milestones.
- Coordinate protocol and GCP training of the staff at research sites
- Analyse and review performance targets, and other deliverables and take relevant action to achieve study milestones
- Be responsible for close down and archiving activities
- Assist with the coordination and facilitation of a CPTU /CPG PPI involvement group
- You may line manage coordinators/data managers and administrators and will report to and be supervised by the Senior Epidemiologist at the CPG. You will coach and line manage other team members and you will be required to develop strong working relationships with other trial managers 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
Applications are welcomed from skilled trial managers/research managers with proven track records in managing the operational delivery of complex projects
This post will be offered on a fixed-term contract for 10 months.
This is a full-time post - 100% full time equivalent.
(80% FTE may be considered)
Communication and Networking:
- Act as the main point of communication on assigned projects to ensure a collaborative approach to the coordination and implementation of studies, maintaining both internal and external excellent working relationships.
- Be able to adapt communication style according to the given audience; demonstrating comprehension and confidence to communicate highly complicated and technical information as well as being able to take complex information and interpret into lay outputs.
- Communicate and administer reports for oversight groups e.g. (trial management or steering groups), ensuring key action points are completed within agreed timeframes.
- Develop effective methods of communicating with primary healthcare professionals as well as target populations to ensure widespread awareness of projects where possible.
- Communicate effectively with stakeholders to facilitate thewriting of research grant applications; contributing to the design, development and feasibility/testing of protocols; case report forms; coding lists, and databases. In addition, writing abstracts; designing posters and contributing to journal articles.
- Assist with the coordination and facilitation of a CPTU / CPG PPI involvement group.
- Act as an ambassador for the KCL CPG.
Decision Making, Planning & Problem Solving:
- Provide leadership and oversight on relevant strands of projects within KCL CPG and other organisations to ensure that they are delivered on time and to budget.
- Use excellent analytical skills to understand complex and at times, fragmented information and independently propose solutions where there is variation in expert opinion or information not available.
- Identifify and suggest resolution to problems ¿ To have the ability to know when it is appropriate to seek the assistance of senior staff to assist in making collaborative decisions while also having the ability to make independent decisions that have implications on their own work, the work of others and the project overall.
- Manage and organise the work resources of themselves and others working on assigned projects to plan and manage projects according to project milestones, ensuring the efficient resource utilisation.
- Liaise with departmental colleagues for the financial management of projects.
- Proactively drive the development of communications, training and/or guidance documents and where there is a need to resolve unpredicted problems.
- Utilise time management skills to prioritise own work, but also allow for flexibility to react to unexpected events, as and when they arise.
- Monitor and report on risk dynamically throughout the relevant projects.
- Carry out effective scoping, planning and delivery of the relevant aspects of the projects ensuring timescale, budget and quality expectations are adhered to.
- Oversee trial activities, in particular related to protocol and GCP compliance and data collection
- Ensure the smooth running of all project related aspects at both the sites and within the CPG, being the main contact person to problem-solve relevant issues that arise.
- Develop and/or approve standard operating procedures for trial processes and ensure other members of staff are fully trained to understand and follow them.
- Responsible for the collection, processing and secure storage of the project documentation.
- Responsibility for gaining and maintaining all relevant approvals for the project where applicable.
- Plan and organise day-to-day work activity within the necessary time frames.
- To negotiate, on behalf of the CPG, the best possible financial and contractual terms for projects.
- Represent projects at national and international meetings as deemed appropriate.
- Travel across London, as required, liaising with key stakeholders, laboratories and research sites (pending COVID restrictions).
- Ensure the study runs according to the principles of ICH GCP, UK Policy Framework for Health and Social Care Research standards, sponsor guidelines and CPTU Standard Operating Procedures by carrying/coordinating relevant monitoring activities ensuring sites are fit for purpose.
- Manage the recording, tracking and archiving requirements of clinical trials conducted within the CPG
Analysis & Research:
- Data collection - ensure all data required for the project is collected and is of a high quality as stipulated in the study protocol.
- Look for early trends in recruitment or data with excellent attention to detail.
- Work with the trial statistician, performing preliminary and routine data analysis.
- Drafting and preparation of reports and presentations where appropriate.
- The postholder will line manage team members where applicable/ required, establishing clear objectives and standards, ensuring ongoing appraisals and development and applying KCL policies appropriately to engage and motivate them in support of wider trial unit, faculty or institutional objectives.
Teamwork, Teaching & Learning Support:
- Contribute to the CPTU Quality Management System.
- Form excellent working relationships with colleagues both internal and external.
- Undertake presentations/demonstrations as required.
- Make a direct input into the operations of the CPTU and its relationship with the wider research community. For example, attending and contributing to meetings and workshops that establish and implement national and international standards in long term follow-up. Ensure good compliance with GCP, regulatory legislation and ethical frameworks.
- To undertake such administrative, managerial and other duties as are reasonably to be expected of a member of staff of this level of seniority, as agreed with line manager.
- Sensory/Physical Demands & Work Environment:
- Willing to work across multiple London sites.
- Based in an office but may also attend conferences, seminars, site visits and training courses outside the organisation.
- Attention to detail and excellent written and verbal communication skills are essential.
- Show consideration to others and maintain good working relations with other departments.
- Required to have a high level of awareness of confidentiality, and general tact and diplomacy. Show sensitivity to those who many need help, or in extreme cases show signs of distress.
- Be aware of the issues relating to working in an open-plan environment and the potential effect that this has on both one's own work, and that of others.
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
- Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse)
- An understanding of ICH/GCP guidelines and other applicable regulations, including the regulations governing the research use of in vitro diagnostics
- Experience in clinical research management or coordination including project governance, data management and monitoring
- Excellent IT skills including working with complex databases and management information systems
- Understanding of medical terminology, either through study or working in a medical environment
- 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
- Understanding of NHS research structure and organisation
- The ability to be proactive and predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them
- Ability to work, on own initiative and prioritise own schedule without supervision
- Willingness to be flexible and provide support wherever required
- 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
- Ability to show attention to detail and high standards of accuracy in all aspects of work
- Experience of working within multidisciplinary teams (e.g. clinicians, academics, statisticians, communication professionals or policy makers).
- Past experience of working with vendors on a clinical research project
1. Formal qualification in clinical trials (or working towards one) and/or post graduate qualification with a research methodology element
2. Experience of primary care research
3. Experience of financial planning and implementation
4. Experience of supervising other staff
5. Proven experience of all stages of a clinical trial from start up to close-out
This post is based at Guy's Hospital, London Bridge but will be remote working until further notice.
This post is subject to Disclosure and Barring Service clearance.