Job summary
University Hospitals Plymouth NHS Trust is seeking an experienced, on-site Trial Manager to lead a portfolio of Trust-sponsored radiology trials from inception to closeout.
The role covers study design, protocol development, study set-up (including regulatory approvals), delivery, reporting, and publication. You will coordinate a multidisciplinary team (e.g. clinicians, statisticians, database programmers, data managers/clinical trial assistants) and provide oversight and reporting for Trust sponsored radiology research.
Working closely with the Senior Leadership and governance teams, you will ensure radiology portfolio of UHP sponsored trials are conducted in full compliance with applicable clinical trial regulations.
This post may be suitable for someone who has experience of working within a CTU environment or previous management of a portfolio of academic research
Preference will be given to internal Trust staff, as well as 'Priority' and 'At Risk' status including NHS At Risk staff throughout Devon who are able to display recent relevant experience as dictated by the Person Specification.
For more information, please contact:
Dr Paul Jenkins
pjenkins1@nhs.net
01752 430838
Or
Muchi Kanengoni
m.kanengoni1@nhs.net
01752 432195
Main duties of the job
o The Radiology Trial Manager is responsible for operational and management aspects of a suite of Radiology project from inception to delivery.
o The post holder is required as appropriate to provide leadership and involve other members of the wider R&D Directorate to fulfil the remit of individual projects.
o The post holder will function as an expert resource, first point of contact and on-going liaison for all R&D stakeholders involved with the management of the Trusts portfolio of radiology research.
o The post holder will be expected to produce clear project plans, trackers and updates to the Radiology research team feeling into the R&D Governance Team. They will be responsible for notifying of any slip in progress and recommendations for required action.
About us
We are a people business - where every member of staff matters and can make a difference. Patients are at the heart of everything we do. Joining University Hospitals Plymouth NHS Trust means becoming part of a team of dedicated staff, who are committed to leading the way through innovation, clinical excellence and great customer care. The Trust has great opportunities for career development in a highly progressive working environment. We offer all of this in a vibrant, modern city with a historic reputation for adventure. PLEASE NOTE THAT ALL COMMUNICATION WILL BE ELECTRONIC, PLEASE CHECK YOUR EMAIL ACCOUNT REGULARLY. If you have any issues with applying online and need additional support including reasonable adjustments with the application process please contact the recruitment manager for this post who will put you in touch with the recruitment team. We recognise that work life balance is important for our colleagues and so we invite requests from applicants around less than full time/flexible working for our advertised roles. Please contact the recruiting manager to discuss this prior to your application submission. We commit to giving this full consideration in each case. We encourage people from diverse backgrounds to apply for our roles, as diversity strengthens our teams. It is sometimes necessary to close vacancies before the closing date. If you have not heard from us within 4 weeks of the closing date, please assume that you have not been shortlisted.
Job description
Job responsibilities
Trial set-up and initiation Coordinate the set-up and conduct of radiology research projects. Contribute to trial design, protocol development and funding applications together with CI, statistician and other members of the team, under the supervision of the radiology senior investigators and the Trust's R&D Governance Team. Input into trial protocols, prepare funding applications for new study proposals and working with the R&D Finance Manager support the preparation of trial budgets and grant applications. Contribute to preparation of essential trial documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), R&D Research Advisor, Clinical Fellow 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 R&D Governance team including the CI, clinical fellow (where relevant) Clinical Trial Database Programmer (CTDP) and Statistician. Contribute to preparation and submission of applications for ethics, regulatory, Sponsor, and other approvals that may be required in order to conduct the trial. Ensure all the required approvals and agreements are in place before the trial opens to recruitment. Ensure all supplies and equipment are available and distributed appropriately Set-up trial specific procedures including monitoring plans in accordance with UHP (in its capacity as Sponsor) SOPs to ensure the efficient management of the trial Set-up up electronic Trial Master File within the Trusts electronic management system and support research sites in the setup and maintenance of electronic Investigator Site Files. Coordinate set-up of trial oversight committees and charters in collaboration with CI, statistician and other members of the team for Sponsored studies. Plan and perform site initiation visits ensuring sites have all applicable documentation in place and that principal investigators and site staff understand the protocol and their responsibilities within the trial
For further details please see attached JD and PS
Job description
Job responsibilities
Trial set-up and initiation Coordinate the set-up and conduct of radiology research projects. Contribute to trial design, protocol development and funding applications together with CI, statistician and other members of the team, under the supervision of the radiology senior investigators and the Trust's R&D Governance Team. Input into trial protocols, prepare funding applications for new study proposals and working with the R&D Finance Manager support the preparation of trial budgets and grant applications. Contribute to preparation of essential trial documents, including protocol, patient information sheets in collaboration with Chief Investigator (CI), R&D Research Advisor, Clinical Fellow 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 R&D Governance team including the CI, clinical fellow (where relevant) Clinical Trial Database Programmer (CTDP) and Statistician. Contribute to preparation and submission of applications for ethics, regulatory, Sponsor, and other approvals that may be required in order to conduct the trial. Ensure all the required approvals and agreements are in place before the trial opens to recruitment. Ensure all supplies and equipment are available and distributed appropriately Set-up trial specific procedures including monitoring plans in accordance with UHP (in its capacity as Sponsor) SOPs to ensure the efficient management of the trial Set-up up electronic Trial Master File within the Trusts electronic management system and support research sites in the setup and maintenance of electronic Investigator Site Files. Coordinate set-up of trial oversight committees and charters in collaboration with CI, statistician and other members of the team for Sponsored studies. Plan and perform site initiation visits ensuring sites have all applicable documentation in place and that principal investigators and site staff understand the protocol and their responsibilities within the trial
For further details please see attached JD and PS
Person Specification
Knowledge and Experience
Essential
- oDemonstrate clear understanding of clinical research lifecycle with the NHS environment
- oStrong understanding of research governance frameworks and understanding
- oDemonstrable experience in setting up research projects from design to initiation
- Significant demonstrable experience of working in partnership and collaboratively with internal and external stakeholders across a health and social care economy including multi-disciplinary teams.
- oDemonstrable commitment to a patient centred approach in service development, planning and improvements
- oAbility to prioritise and manage own and others workload with effective forward planning.
- Able to demonstrate proven evidence of supporting delivery of a service improvement or project skills in an environment influenced both by internal and external changes
- Demonstrable line management experience
- Good understanding of NHS systems, processes and current developments and vision within the NHS at a local, regional and national level
- Demonstrable project management experience and use of Microsoft Office applications
Desirable
- Demonstrable budget management experience
- Demonstrable Commercial experience working across organisations
- Demonstrable experience within strategic development within a healthcare setting
Aptitude and Abilities
Essential
- Enthusiastic, reliable and conscientious
- Ability to maintain patient and business confidentiality at all times
- Meticulous in approach and highly attentive to detail
- Assertive with tact and diplomacy
- Adaptable to change
Qualifications
Essential
- Educated to degree level or equivalent demonstrable experience.
- Proven Evidence of continual professional development.
- Commitment to on-going learning/training
Desirable
- Project Management qualification
Person Specification
Knowledge and Experience
Essential
- oDemonstrate clear understanding of clinical research lifecycle with the NHS environment
- oStrong understanding of research governance frameworks and understanding
- oDemonstrable experience in setting up research projects from design to initiation
- Significant demonstrable experience of working in partnership and collaboratively with internal and external stakeholders across a health and social care economy including multi-disciplinary teams.
- oDemonstrable commitment to a patient centred approach in service development, planning and improvements
- oAbility to prioritise and manage own and others workload with effective forward planning.
- Able to demonstrate proven evidence of supporting delivery of a service improvement or project skills in an environment influenced both by internal and external changes
- Demonstrable line management experience
- Good understanding of NHS systems, processes and current developments and vision within the NHS at a local, regional and national level
- Demonstrable project management experience and use of Microsoft Office applications
Desirable
- Demonstrable budget management experience
- Demonstrable Commercial experience working across organisations
- Demonstrable experience within strategic development within a healthcare setting
Aptitude and Abilities
Essential
- Enthusiastic, reliable and conscientious
- Ability to maintain patient and business confidentiality at all times
- Meticulous in approach and highly attentive to detail
- Assertive with tact and diplomacy
- Adaptable to change
Qualifications
Essential
- Educated to degree level or equivalent demonstrable experience.
- Proven Evidence of continual professional development.
- Commitment to on-going learning/training
Desirable
- Project Management qualification
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
