About this role
Job summary
Come and join a large, experiencedand dynamic research management team at the Leicester Diabetes Centre. We are looking for an ambitious Trial Manager to support theset-up, management and delivery of research studies and clinical trials in diabetes and otherlong-term health condition
The Leicester Diabetes Centre is one of the largest facilities in Europe for conductinghigh-qualityclinical research in diabetes and otherlong-termhealth conditions. We are committed to improving the lives of people living with these conditions through innovative research andevidence-basedpractice.
The Centre is a partnership between the NHS, the National Institute for Health Research (NIHR), University Hospitals of Leicester NHS Trust, and is academically affiliated with the University of Leicester.
We host a range of prestigious NIHR-fundedinfrastructure, including the NIHR Applied Research Collaboration (ARC), the NIHR Biomedical Research Centre (BRC) theme in Diet, Lifestyle and Physical Activity, and theNIHR-fundedCommercial Research Delivery Centre (CRDC). We also attract funding from the British Heart Foundation, the European Union, the Medical Research Council and Diabetes UK.
PREVIOUS APPLICANTSMAY NOT APPLY.
Main duties of the job
You will join a team of research administrators, trial coordinators and trial managers working across single-andmulti-sitestudies. Your role will be to ensure thatallocatedstudies receivetimelyandappropriate oversightto reach time and target, using diplomacy andstrong communication skills to manage challenges along the way. The role may involve travel across the East Midlands to support research sites.
You will be expected to line-manageone or more administrative staff and may supervise the work of a Trial Coordinator. Please note that this role requires regularon-siteattendance.
About us
Our new strategy, developed with the support and feedback of colleagues, patients, and partners, is our compass for the next seven years (2023-2030).
We have four primary goals:
high-quality care for all, being a great place to work, partnerships for impact, and research and education excellence And we will embed health equality in all we do - taking active steps to reduce the avoidable differences in healthcare that some people face, working in partnership with communities.
Our strategy is underpinned by new values and we will work to ensure they are an everyday reality for all:
we are compassionate, we are proud, we are inclusive, and we are one team This is an exciting moment as we look to the future with clarity on what we already do well and where we need to focus our energies to make an even bigger difference for the people we serve.
About the University Hospitals of Leicester NHS Trust:
https://www.uhleicester.nhs.uk
Job description Job responsibilities
This is an excellent opportunity for someone with trial management or coordination experience who enjoys a challenge, uses their initiative, and can adapt to the changing demands of research.
You will need to be selfmotivated, an effective communicator, and confident working both independently and as part of a wider team.
Timely set-up of studies, providing input into study protocols, IRAS forms,patient and GP facing documentation, case report forms, remote data entrysystems and all associated documentation as relevant to role.
Set up participating sites by undertaking site initiation visits, remotely and/or inperson as necessary. Identify and undertake feasibility of sites, ensuring allparticipating sites have received relevant trial specific training. Facilitateapprovals for sites to open to recruitment and monitor progress of each trial siteand take appropriate action.
Efficient and effective set-up and maintenance of internal study managementsystems.
Time and target delivery of studies.
Management of study recruitment which will include the development ofrecruitment plans and the leadership of recruitment strategies for examplecommunity events, leaflet drops etc.
Timely and accurate reporting of study progress, finance, and study relatedreporting (i.e., protocol deviations, serious adverse event, and adverse eventreporting).
Efficient and effective set-up and maintenance of trial master file including all financial paperwork to permit clear audit trail of spend.
Facilitate meetings of trial committees and be responsible for ensuring relevantand timely updates for project stakeholders.
Develop and maintain good working relationships across the department.
Efficient and effective staff training for study related procedures.
Motivate, develop, and support staff that the post holder line manages.
Please see Job description for further details
Person Specification
Training and Qualifications Essential
Degree / or equivalent qualification in a science or health related discipline or a degree in another field with experience in clinical trials or project management or significant equivalent experience in a relevant field. Leadership qualification at certificate level or equivalent experience.
Desirable
Higher degree qualification (e.g., MSc) in clinical trials or a health-related discipline. Project Management Qualification
Experience Essential
Minimum of 2 years' experience of running or delivering clinical research studies/trials. Experience of working in a large complex multi professional organisation. Must have experience within a supervisory/management role. Sound knowledge of the principles of research governance and ICH-GCP Experience of creating research ethics applications including all supporting documentation and knowledge of HRA and MHRA application process and requirements including experience of applying for substantial amendments to the study protocol Facilitation and communication skills both written and verbal appropriate to the project.
Desirable
Experience of managing a budget. Data quality management. Previous NHS experience or Higher Education Institution
Communication and Relationships Skills Essential
Excellent communication skills written and verbal - able to communicate at all levels with well-developed networking and influencing skills. Ability to work autonomously Ability to work effectively within and direct a team or individual team members
Analytical and Judgement Skills Essential
Demonstrate consistent level of attention to detail in relation to study documentation and data collection and inputting. Competent with Microsoft software (e.g., Word, Excel and Powerpoint)
Skills Essential
Leadership and motivational qualities Planning and organisational skills, with a methodical approach and the ability to pay attention to detai Ability to work to deadlines/stability under pressure Ability to use initiative. Problem solving skills Excellent communication skills written and verbal - able to communicate at all levels with well -developed networking and influencing skills. High level of computer literacy Ability to prioritise own and others workload and practice effective time management. Excellent presentation skills Understand, interpret and critically analyse data and information and prepare progress reports. Understand and use quality management systems. Actively manage own personal development.
Desirable
Understand and use project management tools.
Planning and Organisation Skills Essential
Project Management Skills Ability to work to multiple conflicting deadlines. Experience in creating a Gantt chart and recruitment charts. Experience in report writing. Experience in budget management.
Physical skills Essential
Ability to travel to other sites within UHL and across UK with some international travel expected.
Equality, Diversity and Inclusion Essential
Able to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs. All staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others.-
Other requirements specific to the role Essential
Ability to work flexibly. Ability to work as part of a team. Reliable and credible in the role.
Commitment to Trust Values and Behaviours Essential
Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours.
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.
Certificate of Sponsorship 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).
Employer details Employer name University Hospitals of Leicester NHS Trust
Address Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Employer's website https://www.jobsatleicestershospitals.nhs.uk/ (Opens in a new tab)