Trial/Project Manager

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Job summary

Come and join a large, experienced and dynamic research management team. Here at the Leicester Diabetes Centre we are looking for an ambitious Trial Manager to work on the set up, management and delivery of research studies and clinical trials in the areas of diabetes and other long term health conditions.

Leicester Diabetes 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.

This is an exciting opportunity for someone with trial management or coordination experience, who relishes a challenge, is keen to use their own initiative, and is flexible to the changing demands of research. You need to be self-motivated, a strong communicator, and be able to work independently within a team environment.

This full-time position will be offered at 37.5 hours over Monday to Friday. For this role you must be able to attend the office in person.

PREVIOUS APPLICANTS MAY NOT APPLY

Main duties of the job

You will join a team of research administrators, trial coordinators and trial managers working on single or multi-site research studies/clinical trials. Your role will be to ensure allocated studies receive timely and appropriate management to reach time and target, managing any challenges and issues along the way with diplomacy and highly developed communication skills. This may involve travel across the East Midlands to support research sites. You will be expected to line manage one or more administrative staff and will likely supervise the work of a trial coordinator.

The Centre forms one of the largest facilities in Europe for conducting first class clinical research in diabetes and other long term health conditions. We are dedicated to ensuring that people with diabetes and other long term health conditions live long, healthy lives.

The centre has attracted a range of prestigious National Institute of Health Research (NIHR) funded infrastructure and other funding notably from the British Heart Foundation, European Union, Medical Research Council and Diabetes UK. The centre also hosts a local NIHR Applied Research Collaboration (ARC), and NIHR BRC (Biomedical Research Centre) theme in Diet, Lifestyle and Physical Activity, and (NIHR)-funded Patient Recruitment Centre (PRC) for commercial research.

About us

We are one of the biggest and busiest NHS trusts in the country, incorporating the General, Glenfield and Royal Infirmary hospitals. We have our very own Children's Hospital and run one of the country's leading heart centres.

Our team is made up of more than 17,000 staff providing a range of services primarily for the one million residents of Leicester, Leicestershire and Rutland.

We work with partners at the University of Leicester and De Montfort University providing world-class teaching to nurture and develop the next generation of doctors, nurses and other healthcare professionals, many of whom go on to spend their working lives with us.

Our purpose is to provide 'Caring at its best' and our staff have helped us create a set of values that embody who we are and what we're here to do. They are:We focus on what matters mostWe treat others how we would like to be treatedWe are passionate and creative in our workWe do what we say we are going to doWe are one team and we are best when we work together

Our patients are at the heart of all we do and we believe that 'Caring at its best' is not just about the treatments and services we provide, but about giving our patients the best possible experience.

About the University Hospitals of Leicester NHS Trust (leicestershospitals.nhs.uk)

Job description

Job responsibilities

This post will be working within the research delivery team ofthe Leicester Diabetes Centre (LDC). The delivery team is responsible for the set-up and delivery of all LDC studies and trials. Depending on the type, complexity and stage of the studies the post holder may manage one or more studies to ensure they are completes on time, to target, within budget, and in-line with regulatory requirements and good clinicalpractice. All tasks between study set-up to data-lock come under the responsibility of the trial manager including all quality assurance processes and study finance.The post holder will be expected to work closely with the Senior Research Associate to report study progress and recruitment status to the Lead Trial & Quality Manager, LDC Operations Director and study Principal Investigator and trouble shoot, and develop and instigate recovery plans if the project is not running according to plan.You will delegate trial specific tasks to the project team e.g. research administrator(s) and/or study co-ordinator(s) to facilitate study delivery. You will train and develop these members of staff to ensure they are able to carry out their study specific tasks, and to monitor their progress and effect remedial solutions when, and if, required. You will assume line management duties as required.You will work across all UHL sites, and local CCGs as required, will liaise with the University of Leicester and other external organisations such as research councils, charities, other Trusts and Universities and will be expected to undertake flexible working arrangements to meet projectdemands i.e. working some early and late shifts and occasional weekends. There may be the need to undertake site visits nationally for multi-site trials.Your remit will additionally involve the development, implementation and maintenance of efficient research management processes to support efficient trial management and reporting

Job description
Job responsibilities

This post will be working within the research delivery team ofthe Leicester Diabetes Centre (LDC). The delivery team is responsible for the set-up and delivery of all LDC studies and trials. Depending on the type, complexity and stage of the studies the post holder may manage one or more studies to ensure they are completes on time, to target, within budget, and in-line with regulatory requirements and good clinicalpractice. All tasks between study set-up to data-lock come under the responsibility of the trial manager including all quality assurance processes and study finance.The post holder will be expected to work closely with the Senior Research Associate to report study progress and recruitment status to the Lead Trial & Quality Manager, LDC Operations Director and study Principal Investigator and trouble shoot, and develop and instigate recovery plans if the project is not running according to plan.You will delegate trial specific tasks to the project team e.g. research administrator(s) and/or study co-ordinator(s) to facilitate study delivery. You will train and develop these members of staff to ensure they are able to carry out their study specific tasks, and to monitor their progress and effect remedial solutions when, and if, required. You will assume line management duties as required.You will work across all UHL sites, and local CCGs as required, will liaise with the University of Leicester and other external organisations such as research councils, charities, other Trusts and Universities and will be expected to undertake flexible working arrangements to meet projectdemands i.e. working some early and late shifts and occasional weekends. There may be the need to undertake site visits nationally for multi-site trials.Your remit will additionally involve the development, implementation and maintenance of efficient research management processes to support efficient trial management and reporting

Person Specification

Training & Qualifications

Essential

• Degree / or equivalent qualification in a science or health related discipline or a degree in another field with experience in clinical trials.

Desirable

• Higher degree qualification (e.g. MSc) in clinical trials or a health related discipline

Experience

Essential

• Minimum of 3 years experience of managing or delivering clinical research studies/trials in a large complex multi professional organisation (e.g., within the NHS or other relevant institution)
• Must have experience within a supervisory/management role
• Experience with creating research ethics applications including all supporting documentation including knowledge of HRA and MHRA application process and requirements
• Competent with Microsoft software (Word, Excel and Powerpoint)

Communication and relationship skills

Essential

• Ability to work autonomously
• Ability to work effectively within and direct a team or individual team members

Analytical and Judgement skills

Essential

• Understand, interpret and critically analyse data and information and prepare progress reports
• Ability to work to deadlines/ stability under pressure

Skills

Essential

• Leadership and motivational qualities
• Ability to exercise initiative
• Ability to prioritise own and others workload and practice effective time management

Planning and organisation skills

Essential

• Planning and organisational skills, with a methodical approach and the ability to pay attention to detail

Other requirements specific to the role

Essential

• Ability to work flexibly

Person Specification
Training & Qualifications

Essential

• Degree / or equivalent qualification in a science or health related discipline or a degree in another field with experience in clinical trials.

Desirable

• Higher degree qualification (e.g. MSc) in clinical trials or a health related discipline

Experience

Essential

• Minimum of 3 years experience of managing or delivering clinical research studies/trials in a large complex multi professional organisation (e.g., within the NHS or other relevant institution)
• Must have experience within a supervisory/management role
• Experience with creating research ethics applications including all supporting documentation including knowledge of HRA and MHRA application process and requirements
• Competent with Microsoft software (Word, Excel and Powerpoint)

Communication and relationship skills

Essential

• Ability to work autonomously
• Ability to work effectively within and direct a team or individual team members

Analytical and Judgement skills

Essential

• Understand, interpret and critically analyse data and information and prepare progress reports
• Ability to work to deadlines/ stability under pressure

Skills

Essential

• Leadership and motivational qualities
• Ability to exercise initiative
• Ability to prioritise own and others workload and practice effective time management

Planning and organisation skills

Essential

• Planning and organisational skills, with a methodical approach and the ability to pay attention to detail

Other requirements specific to the role

Essential

• Ability to work flexibly

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 .

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. .

Additional information
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 .

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. .

Employer details

Employer name

University Hospitals of Leicester NHS Trust
Address

Leicester General Hospital

Gwendolen Road

Leicester

LE5 4PW

Employer's website