This post is responsible for the development, oversight and delivery of the Cancer Treatment Effects theme agenda and the National CPC programme agenda.Main duties of the job
This post is responsible for the development, oversight and delivery of the Cancer Treatment Effects theme and the National CPC programme agenda. The post-holder will be a senior Programme Manager who will provide the operational and project/portfolio management of the CTE and the National CPC programme activities, manage collaborations and relationships between the participating members and external partners and stakeholders, including industry. They will ensure effective liaison between a range of researchers across RM Clinical Research Units and ICR to facilitate the establishment of new studies and growing the CTE theme portfolio. In addition, they will also lead on the set-up and delivery of the National CPC programme, including the development and maintenance of constructive relationships with the external stakeholders.
The ideal candidate will have significant project management experience. They will be proactive and highly organised, with a strong administrative background and an excellent attention to detail.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 descriptionJob responsibilities For further information please refer to the Job Description/Person Specification Collaboration management
Project management Trial set-up and initiation
- Act as the driving force between the CTE theme/CPC programme members, funders and external stakeholders
- Develop a thorough working knowledge of research capabilities, activities and collaborative potential across cancer treatment effects.
- Lead the set-up and delivery of the National CPC programme, including the implementation of collaboration agreements and operational processes across all participating collaboration centres.
- Be the primary point of contact for activities e.g. liaising with the finance, operations, legal and academic staff at the participating universities and NHS Trusts.
- Collaborate with the Perioperative and Surgical Unit Operations Manager to avoid duplication of efforts in managing the surgical portfolio related to the CTE Theme.
- Plan and prepare for meetings on behalf of the Chairs, including the CTE theme meeting
- Troubleshooting for external partners, university and NHS staff participating in the CTE and the CPC and their projects
- Input into clinical trial protocols, prepare funding applications for new study proposals and prepare clinical trial budgets.
- Contribute to clinical trial design, protocol development and funding applications together with Chief Investigator (CI), statistician and other members of the team.
- Contribute to preparation of essential clinical trials documents, including protocol, patient information sheets in collaboration with the CI, clinical fellows etc.
- Contribute to preparation of trial documentation e.g. trial guidance notes, case report forms (CRFs), monitoring plans, in collaboration with relevant members of the trial management team including the CI, clinical fellow (where relevant), monitor, database programmer and statistician
- To hold regular review meetings of the portfolio and monitor progress against plan.
- To identify barriers to set up and delivery of trials and recommend actions, escalating to the Head of Research Delivery or Assistant Director of Clinical Research where appropriate.
- To report on trial performance.
- Produce a regular update report on the progress of all studies open or in feasibility, identifying risks and including mitigation plans as required in conjunction with the senior trial managers.
Communication / relationships
- To work with researchers to ensure full costing of clinical research to be managed by RM CTU, using expert knowledge of AcoRD categorisation and attribution.
- Ensure the financial viability of the portfolio and team tasked with managing it.
- Build strong relationships and have direct communication with other members of the research team to ensure the smooth running of a clinical trial or research project during its life cycle.
- Communicate with external stakeholders, e.g. ethics committees, universities and other R&D departments.
- First point of contact for queries on assigned studies including hospital site personnel (i.e. clinicians, nurses, data managers).
- Contribute to /arrange the planning and organisation of trial meeting as appropriate for the trial including investigators/ research nurses/trial coordinators.
- Educated to degree level (e.g. BA or BSc) or equivalent experience
- Good Clinical Practice certification
- Higher degree qualification (e.g. MSc or PhD) in a relevant subject, preferably in the medical or biological sciences.
- Project management qualification (eg PRINCE 2).
- Extensive experience of the sponsor-level management of MHRA and HTA regulated clinical trials in an academic environment.
- Experience of safety reporting to regulatory authorities.
- Experience of establishing, developing and managing a team.
- Experience of working across a large organisation, including operating and managing across complex, multi-partnered projects with the NHS and commercial organisations.
- Experience of developing systems and processes to allow efficient management and conduct of multi-centre clinical trials
- Experience of communicating effectively with all levels of staff - written and verbal
Skills / knowledgeEssential
- Experience of developing and implementing new SOPs and processes.
- Detailed knowledge of UK clinical trial regulations, GCP and regulatory frameworks
- Knowledge of developing budgets for clinical trials and practical use of AcoRD
- A detailed understanding of the clinical trials approval process to conduct clinical research in the UK
- Knowledge of the requirements of clinical trials and clinical research projects during their life cycle especially at the start-up stage
- Exceptional organisational skills, including excellent attention to detail, meetings management and record keeping
- Confidence and diplomacy when dealing with stakeholders in NHS Trusts, universities and industry who have diverse levels of experience and seniority
- Proven problem-solving skills
- Excellent presentation skills
- Knowledge of clinical trial design issues in conducting oncology studies
- Proficient in the using PC based Windows and Microsoft Office software including the internet and e-mail.
- Detailed knowledge of clinical trial methodology and /or statistical issues as they pertain to clinical trials.
- Excellent report writing skills.
- Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately.
- Maintain a positive and enthusiastic attitude towards tasks and their goals.
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way.
- Able to work under pressure, methodical in approach, with effective problem-solving ability
- Ability to work effectively to tight deadlines under direction and on own initiative
- A high level of accuracy and attention to detail
- Flexible attitude and capable of dealing with changing working conditions.
- Clear understanding of and interest in cancer research.
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results
- Willing and able to coach and train others.
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