Job summary
An exciting new opportunity has become available for an enthusiastic, forward thinking, and self motivated professional to join the Clinical Trials Pharmacy team at The Royal Marsden.
This is a remarkable time to join our Clinical Trials Department. Our service is committed to delivering outstanding support to our patients and staff, and we are proud to be involved in cutting edge research that shapes the future of cancer care. At The Royal Marsden, we play a key role in pioneering treatments, including advanced therapies such as vaccines, gene therapy, and CAR T cell therapy.
With the recent implementation of the EPIC digital health record system, we are transforming the way we work. Our ambition is to harness the full potential of EPIC to streamline workflows, enhance efficiency, and move towards a fully digital and paperless pharmacy service.In this role, you will take the lead on pharmacy related clinical trial projects, ensuring the smooth co ordination of trial review and approval processes.
This is a fantastic opportunity to contribute to world leading research within a supportive, collaborative, and innovative environment.
Main duties of the job
o To lead project managements to ensure the timely progression, co-ordination and control of the project with pre-defined objectives, work plans, milestones, deliverables and resources.o To be responsible for the co-ordination of the continuous development, management and delivery in the pharmacy review and approval process of research trials within the Clinical Trials Pharmacy across both sites of the Royal Marsden NHS Foundation Trust.o To be responsible for co-ordination, of the review and approval processes of research trials and support throughout the duration of the study on behalf of both The Royal Marsden as a site, and on behalf of The Royal Marsden and the Institute of Cancer Research as a sponsor, for both new protocols and amendments to existing protocols.o To provide expert advice on aspects of governance in relation to the management of complex studies, various projects to improve performance across Clinical Trials Pharmacy and The Royal Marsden, with the ability to lead where required.o Ensure that all aspects of pharmacy research review and approval are conducted and managed in accordance with Good Clinical Practice, the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, and local standard operating procedures.o To provide advice to ensure compliance with national and local policies and procedures and liaise with staff across all levels of the organisation as well as external stakeholders.
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 please refer to the Job Description & Person Specification.
Act as key point of communication between all research delivery (trial coordinators / research fellows / Principal Investigators) and research management (trial managers / research fellows / Chief Investigators) and the Pharmacy Clinical Trials Team for any new protocol or amendment to existing protocol requiring pharmacy research review and approval.
Oversee the Minimum Document Set, ensuring that relevant and completed documentation is available to initiate pharmacy research review and approval for both new protocols and amendments to existing protocols.
Act as a representative for Clinical Trials Pharmacy in various meetings across the Royal Marsden and with external stakeholders including regulatory authorities, sponsors and other hospital Trusts.
Oversee the updating of pharmacy review and approval records in real time to excellent standards of data quality and integrity and monitor the progress. Communicate deadlines and relevant pressures for completion to ensure a timely and efficient service to research delivery and management staff.
Support the Chief Technician to oversee Pharmacy Clinical Trials Team in aspects of data management, in the improvement of data collection and the monitoring of Key Performance Indicators (KPIs).
Support with preparations for regulatory inspections and internal/external audits.
Ensure that clinical trials pharmacy is compliant with all legal requirements pertinent to research.
Job description
Job responsibilities
For further information please refer to the Job Description & Person Specification.
Act as key point of communication between all research delivery (trial coordinators / research fellows / Principal Investigators) and research management (trial managers / research fellows / Chief Investigators) and the Pharmacy Clinical Trials Team for any new protocol or amendment to existing protocol requiring pharmacy research review and approval.
Oversee the Minimum Document Set, ensuring that relevant and completed documentation is available to initiate pharmacy research review and approval for both new protocols and amendments to existing protocols.
Act as a representative for Clinical Trials Pharmacy in various meetings across the Royal Marsden and with external stakeholders including regulatory authorities, sponsors and other hospital Trusts.
Oversee the updating of pharmacy review and approval records in real time to excellent standards of data quality and integrity and monitor the progress. Communicate deadlines and relevant pressures for completion to ensure a timely and efficient service to research delivery and management staff.
Support the Chief Technician to oversee Pharmacy Clinical Trials Team in aspects of data management, in the improvement of data collection and the monitoring of Key Performance Indicators (KPIs).
Support with preparations for regulatory inspections and internal/external audits.
Ensure that clinical trials pharmacy is compliant with all legal requirements pertinent to research.
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g. BSc) in a relevant subject, or equivalent experience of working in clinical/health research.
- Recognised Good Clinical Practice certification
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject
- Project management qualification.
Experience
Essential
- Extensive experience of working in a clinical research setting as a Clinical Trials Coordinator or Project Manager setting up clinical trials
- Extensive experience of data entry and data management.
- Extensive experience and knowledge of pharmacy clinical trials management
- Experience in writing Standard Operating Procedures for new processes
- Experience in identifying problems, investigate errors/incidents and managing risk and propose solutions CAPAs for complex problems
Desirable
- Experience of using the EDGE and other Database local portfolio management system.
- Experience of working in the NHS in the field of cancer.
- Experience of designing and delivering training
- Experience of managing staff, including sickness, performance, conduct and appraisal process.
Skills Abilities/Knowledge
Essential
- Excellent organisational skills, including excellent attention to detail and record keeping.
- Be able to work in a methodical approach, with a sharp analytical mind and an ability to think laterally
- Significant knowledge of clinical trial regulations and Understanding of the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended
- Effective interpersonal skills with particular ability to communication with multidisciplinary teams at all levels from a wide range of disciplines
- Ability to make decisions and work well under pressure with competing deadlines by prioritising and managing own time effectively and that of others.
- Be able to problem solve, take responsibility and work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Highly computer Literate; evidence of competency with Microsoft Word, Outlook, Excel and PowerPoint and other software database and Artificial Intelligence.
Desirable
- Evidence of effective negotiating and influencing skills.
- Working knowledge of EPIC computer system
Other
Essential
- Flexible attitude and capable of dealing with changing working conditions.
- Able to work on both sites and to be flexible to meet the needs of the role.
Person Specification
Education/Qualifications
Essential
- Degree qualification (e.g. BSc) in a relevant subject, or equivalent experience of working in clinical/health research.
- Recognised Good Clinical Practice certification
- Commitment to continued professional development.
Desirable
- Higher degree qualification (e.g. MSc) in a relevant subject
- Project management qualification.
Experience
Essential
- Extensive experience of working in a clinical research setting as a Clinical Trials Coordinator or Project Manager setting up clinical trials
- Extensive experience of data entry and data management.
- Extensive experience and knowledge of pharmacy clinical trials management
- Experience in writing Standard Operating Procedures for new processes
- Experience in identifying problems, investigate errors/incidents and managing risk and propose solutions CAPAs for complex problems
Desirable
- Experience of using the EDGE and other Database local portfolio management system.
- Experience of working in the NHS in the field of cancer.
- Experience of designing and delivering training
- Experience of managing staff, including sickness, performance, conduct and appraisal process.
Skills Abilities/Knowledge
Essential
- Excellent organisational skills, including excellent attention to detail and record keeping.
- Be able to work in a methodical approach, with a sharp analytical mind and an ability to think laterally
- Significant knowledge of clinical trial regulations and Understanding of the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended
- Effective interpersonal skills with particular ability to communication with multidisciplinary teams at all levels from a wide range of disciplines
- Ability to make decisions and work well under pressure with competing deadlines by prioritising and managing own time effectively and that of others.
- Be able to problem solve, take responsibility and work in a proactive manner to identify new risks and issues and flag upwards appropriately
- Highly computer Literate; evidence of competency with Microsoft Word, Outlook, Excel and PowerPoint and other software database and Artificial Intelligence.
Desirable
- Evidence of effective negotiating and influencing skills.
- Working knowledge of EPIC computer system
Other
Essential
- Flexible attitude and capable of dealing with changing working conditions.
- Able to work on both sites and to be flexible to meet the needs of the role.
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.
