Trial Manager

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Detailed job description and main 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 self-motivated, 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 entry systems and all associated documentation as relevant to role.

Set up participating sites by undertaking site initiation visits, remotely and/or in person as necessary. Identify and undertake feasibility of sites, ensuring all participating sites have received relevant trial specific training. Facilitate approvals for sites to open to recruitment and monitor progress of each trial site and take appropriate action.

Efficient and effective set-up and maintenance of internal study management systems.

Time and target delivery of studies.

Management of study recruitment which will include the development of recruitment plans and the leadership of recruitment strategies for example community events, leaflet drops etc.

Timely and accurate reporting of study progress, finance, and study related reporting (i.e., protocol deviations, serious adverse event, and adverse event reporting).

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 relevant and 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 criteria

• 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 criteria

• Higher degree qualification (e.g., MSc) in clinical trials or a health-related discipline.
• Project Management Qualification

Experience

Essential criteria

• 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 criteria

• Experience of managing a budget.
• Data quality management.
• Previous NHS experience or Higher Education Institution

Communication and Relationships Skills

Essential criteria

• 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 criteria

• 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 criteria

• 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 criteria

• Understand and use project management tools.

Planning and Organisation Skills

Essential criteria

• 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 criteria

• Ability to travel to other sites within UHL and across UK with some international travel expected.

Equality, Diversity and Inclusion

Essential criteria

• 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 criteria

• 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 criteria

• Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours.

Additional Information

Please submit your application form without delay to avoid disappointment; we will close vacancies prior to the publishing closing date if we receive a sufficient number of completed application forms.

Please check the email account (including your junk mail) that you supplied as part of your application on a regular basis following the closing date and throughout the recruitment process, as this is how we will communicate with you.

UHL is an equal opportunities employer. We aim to employ a workforce that reflects the diverse communities we serve. We welcome applications from people from all backgrounds who match our job criteria.

Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible.

UHL is committed to helping colleagues balance the demands of both their work and personal needs through flexible working arrangements wherever reasonably practicable and subject to service needs.

Disclosure and Barring Service Check

Please note if you are successful in obtaining this position and the post involves regulated activity you will be required to undertake a Disclosure & Barring Service check.

The Trust will pay for the check initially and the money will then be deducted from your salary over a three month period commencing on your first month's payment.

The current price of a check is £38 for an enhanced and £18 for a standard check.

COVID 19 Risk Assessment

Due to the current Covid pandemic we have introduced a staff risk assessment into our pre-employment process. This now forms part of the mandatory pre-employment checks that will be carried out if you receive a conditional offer.

The risk assessment is intended to ensure you are able to safely perform your duties in any of our work areas, and if you have been identified as being particularly vulnerable to coronavirus. Our main aim is to reduce risk and to ensure the safety of all new starters to the Trust as well as current staff, patients and visitors.

If it is identified that you are within a vulnerable category, we will endeavor to make reasonable adjustments to accommodate this through discussions with both Occupational Health and your recruiting manager.

Covid Vaccination Status

Covid-19 vaccination remains the best way to protect yourself, family, colleagues and our patients/service users from the Covid-19 virus. We therefore continue to encourage our current and potential colleagues to get vaccinated.

University Hospitals of Leicester NHS Trust holds the principles of equality, diversity and inclusion at the heart of everything it does and all that it stands for. We are committed to developing a workforce that is representative of the community we serve. We welcome applications from the diverse community of Leicester, Leicester and Rutland, to help deliver healthcare services that meets the needs of our diverse communities.

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