Job summary
Band 7 Senior Trials Manager (Sutton based with travel to Chelsea)Early Detection and Diagnosis(ED&D) 1.0 WTE (Full Time)14 months Fixed Term Contract
An opportunity has arisen for a Band 7 Senior Trials Manager post within the Early Detection and Diagnosis Team to primarily support the team and lead the trial management team. The post will be crucial in setting up current projects and sites at various stages, performing relevant duties to complete the required tasks. The post holder will need to be flexible in their approach to maximise service delivery.
NHS Long Term Plan is aiming to diagnose 75% of patients for 3 out of 4 cancer types by 2028, currently this stands at 55% of early diagnosis on average, and lower in high risk cancers, therefore there is a need for an Early Detection and Diagnosis.
The post holder should have sufficient research experience, specially experience in cancer research. To be educated to degree level or equivalent experience, you will work within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP.
The successful applicant should have a flexible approach to their duties and the ability to work both as part of the team as well as independently. In addition; excellent communication, administrative and IT skills and being supportive and open to new initiatives are particularly valued by the team.
Main duties of the job
The Senior Trial Manager will coordinate multifunctional team(s) consisting of clinician(s), surgeon(s), statistician(s), database programmer; data manager/clinical trial assistant to project manage one or more complex clinical trials throughout their lifecycle. This may include protocol development, study set-up (including regulatory approvals), on-going study management/oversight. Working with experienced clinical trial support service staff, the post holder will ensure that all clinical trials areconducted to the relevant clinical trial regulations. In addition the Senior Trial Manager will have line management responsibilities for the Clinical Trial administrator. The role requires a clinical research professional who has extensive experience in clinical trials conduct ideally in different settings (Pharma, Surgical, Academic) and familiarity with the regulatory environment surrounding clinical trials and the implementation of a quality management system as it pertains to clinical trial conduct.
The post holder will be based at our Chelsea site with occasional travel to Sutton
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, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. 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 further information on this role, please see the attached detailed Job Description and Person Specification
- Contribute to clinical trial design, protocol development and fundingapplications together with CI, statistician and other members of the team.
- Input into clinical trial protocols, prepare funding applications for new study proposals and prepare clinical trial budgets.
- Contribute to preparation of essential clinical trials documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), Clinical Research Operations Manager, 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) Clinical Trial Database Programmer (CTDP) and Statistician
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification
- Contribute to clinical trial design, protocol development and fundingapplications together with CI, statistician and other members of the team.
- Input into clinical trial protocols, prepare funding applications for new study proposals and prepare clinical trial budgets.
- Contribute to preparation of essential clinical trials documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), Clinical Research Operations Manager, 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) Clinical Trial Database Programmer (CTDP) and Statistician
Person Specification
Education/Qualifications
Essential
- Educated to degree level or equivalent experience
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences.
- Project Management qualification (eg PRINCE 2)
Experience
Essential
- Experience of working to UK clinical trials regulations
- Previous clinical trial project management experience from protocol development to reporting and archiving
- Previous clinical trial project management experience from protocol development to reporting and archiving
- Experience of preparing REC submissions
- Experience of preparing REC submissions
- Experience of working across organisational boundaries with multidisciplinary teams
- Experience of communicating effectively with all levels of staff - written and verbal
- Clear understanding of and interest in cancer research
- Proven problem solving skills.
- Excellent presentation skills
Desirable
- Experience of developing and implementing new SOPs and processes
- Experience of preparing MHRA, IRMA and other submissions
- Experience of conducting complex clinical trials with IMP
- Experience of regulatory inspections
- Experience of Line Management including managing a team and developing staff
Skills/Knowledge
Essential
- Detailed knowledge of UK Clinical trial regulations, GCP and regulatory framework
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up stage
- Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trials regulations
- Knowledge of clinical trial design issues in conducting oncology studies
- 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
Desirable
- Detailed Knowledge of database set-up and data management processes and procedures necessary to conduct clinical trials
- Detailed Knowledge of Clinical trial methodology and /or statistical issues as they pertain to clinical trials
- Knowledge of developing budgets for clinical trials including AcORD process
- Excellent report writing skills
- Knowledge of Visio and or MS Project
Other Requirements
Essential
- 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
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way
- Ability to work effectively to tight deadlines under direction and on own initiative.
- A high level of accuracy and attention to detail
- Ability to prioritise workload of others while balancing own workload(s).
- Flexible attitude and capable of dealing with changing working conditions
Desirable
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results
- Willing and able to coach and train others
Person Specification
Education/Qualifications
Essential
- Educated to degree level or equivalent experience
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject, preferably in the medical or biological sciences.
- Project Management qualification (eg PRINCE 2)
Experience
Essential
- Experience of working to UK clinical trials regulations
- Previous clinical trial project management experience from protocol development to reporting and archiving
- Previous clinical trial project management experience from protocol development to reporting and archiving
- Experience of preparing REC submissions
- Experience of preparing REC submissions
- Experience of working across organisational boundaries with multidisciplinary teams
- Experience of communicating effectively with all levels of staff - written and verbal
- Clear understanding of and interest in cancer research
- Proven problem solving skills.
- Excellent presentation skills
Desirable
- Experience of developing and implementing new SOPs and processes
- Experience of preparing MHRA, IRMA and other submissions
- Experience of conducting complex clinical trials with IMP
- Experience of regulatory inspections
- Experience of Line Management including managing a team and developing staff
Skills/Knowledge
Essential
- Detailed knowledge of UK Clinical trial regulations, GCP and regulatory framework
- Knowledge of the requirements of clinical trials and clinical research projects during their life-cycle especially at the start-up stage
- Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trials regulations
- Knowledge of clinical trial design issues in conducting oncology studies
- 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
Desirable
- Detailed Knowledge of database set-up and data management processes and procedures necessary to conduct clinical trials
- Detailed Knowledge of Clinical trial methodology and /or statistical issues as they pertain to clinical trials
- Knowledge of developing budgets for clinical trials including AcORD process
- Excellent report writing skills
- Knowledge of Visio and or MS Project
Other Requirements
Essential
- 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
- Ability to work well within a multi-disciplinary team environment in an effective and supportive way
- Ability to work effectively to tight deadlines under direction and on own initiative.
- A high level of accuracy and attention to detail
- Ability to prioritise workload of others while balancing own workload(s).
- Flexible attitude and capable of dealing with changing working conditions
Desirable
- Ability to negotiate, acting in a tactful and confident manner to achieve the desired results
- Willing and able to coach and train others
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
