Royal Marsden
The Urology Clinical Trials Research Unit focuses on research delivery for patients primarily with prostate and bladder cancers. As Senior Trial Manager, you will also be responsible for the development and management of our sponsored portfolio, where RM are acting as sponsor.
The Senior Trial Manager role is a pivotal role, mostly focusing on the set-up and management of RM-sponsored trials, and supporting coordination and management of the hosted portfolio. Experience of trial management is essential, as well as excellent IT and organisational skills. You will be in close liaison with R&D, Chief Investigators and sponsor teams, monitors and auditors, and external pharmaceutical and CRO companies, with a shared goal of ensuring that trials are successfully run and in compliance, with good quality data produced.
The job is based at our Chelsea site, with remote working permitted.
Main duties of the job
To take responsibility for ensuring all clinical trials (primarily hosted with external sponsors) within the urology clinical trials (London) research unit are set-up, conducted and managed in accordance with Good Clinical Practice, Trust SOPs and trial protocols. To manage and lead the administrative team of the urology clinical trials (London) research unit. To manage and oversee the finances and budget of the urology clinical trials (London) research unit, ensuring a balanced portfolio which enables sufficient income generation for the sustainability and development of the team. To lead on business development in the urology clinical trials (London) research unit team to develop a sustainable portfolio of commercial and non-commercial research. Working for our organisation
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. Detailed job description and main responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification: Provide trial coordination support across all uro-oncology studies, including RM sponsored studies as required. Provide line management support to the team of administrative staff. Help obtain quality data outputs from the uro-oncology research unit. Maintain oversight that data and queries are managed in accordance to the study contract. Identify training and development needs of staff in line with departmental and Trust Objectives and ensure all new staff receive core and departmental induction. Ensure performance issues are dealt with in an appropriate and timely manner and follow the Trust's Disciplinary or Poor Performance Procedures where formal action is necessary. Provide expertise and guidance to those in the research unit in all areas of research and facilitate the unit research strategy. To oversee the collection and entry of data into relevant case report forms, and the correct updating of the data validation tool to record patient visits and raise correct invoices in a timely manner. Person specification
Education/Qualifications
Life sciences (or equivalent) degree or relevant experience Recent GCP training Higher Degree qualification (e.g. MSc) Experience/Knowledge
Experience of working in a clinical trials setting as a clinical trial coordinator / manager or equivalent Detailed knowledge of clinical trials, UK Clinical trial regulations, GCP and regulatory framework. Experience of setting up and managing clinical trials Experience of budget management in clinical trials setting Experience of managing/supervising administrative staff Experience of data management, overseeing data quality and resolution of queries Experience of working in the field of oncology Experience of working in an NHS / pharmaceutical setting Experience of sponsored clinical trial management including protocol development and regulatory submission Skills/Abilities
Ability to prioritise workload and work autonomously, and adjust own work in light of unexpected events or changing priorities Able to work effectively to deadlines under direction and on own initiative Excellent administrative and organisational skills, with excellent attention to detail Excellent IT skills including Microsoft Excel and Power point Excellent oral and written communication skills, for day-to-day duties as well as report writing and presentations Excellent interpersonal & communication skills with the ability to deal effectively with a wide range of people Able to negotiate, acting in a tactful and confident manner Experience of developing systems and processes to allow efficient management and conduct of clinical trials The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities. As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve. Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails. Flu Vaccination – What We Expect of our Staff At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease. The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust. Employer certification / accreditation badges #J-18808-Ljbffr
To take responsibility for ensuring all clinical trials (primarily hosted with external sponsors) within the urology clinical trials (London) research unit are set-up, conducted and managed in accordance with Good Clinical Practice, Trust SOPs and trial protocols. To manage and lead the administrative team of the urology clinical trials (London) research unit. To manage and oversee the finances and budget of the urology clinical trials (London) research unit, ensuring a balanced portfolio which enables sufficient income generation for the sustainability and development of the team. To lead on business development in the urology clinical trials (London) research unit team to develop a sustainable portfolio of commercial and non-commercial research. Working for our organisation
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. Detailed job description and main responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification: Provide trial coordination support across all uro-oncology studies, including RM sponsored studies as required. Provide line management support to the team of administrative staff. Help obtain quality data outputs from the uro-oncology research unit. Maintain oversight that data and queries are managed in accordance to the study contract. Identify training and development needs of staff in line with departmental and Trust Objectives and ensure all new staff receive core and departmental induction. Ensure performance issues are dealt with in an appropriate and timely manner and follow the Trust's Disciplinary or Poor Performance Procedures where formal action is necessary. Provide expertise and guidance to those in the research unit in all areas of research and facilitate the unit research strategy. To oversee the collection and entry of data into relevant case report forms, and the correct updating of the data validation tool to record patient visits and raise correct invoices in a timely manner. Person specification
Education/Qualifications
Life sciences (or equivalent) degree or relevant experience Recent GCP training Higher Degree qualification (e.g. MSc) Experience/Knowledge
Experience of working in a clinical trials setting as a clinical trial coordinator / manager or equivalent Detailed knowledge of clinical trials, UK Clinical trial regulations, GCP and regulatory framework. Experience of setting up and managing clinical trials Experience of budget management in clinical trials setting Experience of managing/supervising administrative staff Experience of data management, overseeing data quality and resolution of queries Experience of working in the field of oncology Experience of working in an NHS / pharmaceutical setting Experience of sponsored clinical trial management including protocol development and regulatory submission Skills/Abilities
Ability to prioritise workload and work autonomously, and adjust own work in light of unexpected events or changing priorities Able to work effectively to deadlines under direction and on own initiative Excellent administrative and organisational skills, with excellent attention to detail Excellent IT skills including Microsoft Excel and Power point Excellent oral and written communication skills, for day-to-day duties as well as report writing and presentations Excellent interpersonal & communication skills with the ability to deal effectively with a wide range of people Able to negotiate, acting in a tactful and confident manner Experience of developing systems and processes to allow efficient management and conduct of clinical trials The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities. As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve. Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment. All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails. Flu Vaccination – What We Expect of our Staff At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease. The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust. Employer certification / accreditation badges #J-18808-Ljbffr