Trial Manager – College of Medical and Dental Sciences

Full-time University of Birmingham in Specialist/Professional Email Job
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Job Description

JOB DESCRIPTION

Position Details

College of Medical and Dental Sciences

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £31,396 to £33,966 with potential progression once in post to £38,205

Grade: 6

Full Time, Fixed Term contract up to May 2026

Closing date: 18th July 2024

 

Our offer to you

People are at the heart of what we are and do.

The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success.

We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide-range of functions in Edgbaston and in our campus in Dubai, there are plenty of opportunities for you to be able to develop your career at the University.

We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work.

Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high quality subsidised day nurseries.

The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum and botanical gardens.

Find out more about the benefits of working for the University of Birmingham

Role Summary

As a member of one or more trial working groups, coordinate one or more designated clinical trials according to predefined standards, policies, procedures, frameworks and legislation, ensuring appropriate records are kept.

Main Duties

Main duties

  • Set up clinical sites, prepare ethics committee and regulatory submissions, ensuring that staff at participating
  • sites understand and are able to comply with the trial protocol.
  • Support each site with recruitment and monitor the progress of each site, including trial protocol compliance.
  • Conduct quality assurance and audit visits to sites.
  • Address any practical issues reported by sites.
  • Contribute to the design, analysis, publication and presentation of the research. This may involve contributing to
  • the following: writing research grant applications; designing, developing and feasibility test of protocols; case
  • report forms; coding lists and databases; writing abstracts; designing posters; journal articles.
  • Provide regular feedback and reports on the progress of the trial, including newsletters, meetings, maintaining a
  • trial website.
  • Ensure trial data is collected, processed and stored accurately and to agreed deadlines.
  • Train and supervise other internal and external collaborators involved in data management in the rules and
  • procedures to use.
  • Create and document guidance notes, procedures and forms for the conduct of the trial, and ensure internal and
  • external collaborators are trained to understand and follow them.
  • Create trial management tools including databases.
  • Enter trial data onto the trial database(s), and monitor it to identify missing, contradictory or incorrect data and
  • then take actions to resolve these issues within a reasonable timescale.
  • Coordinate and support the trial management group and oversight groups and organisations.
  • Represent the trial management team at meetings.
  • Keep up to date with the current research literature and developments in the field.
  • Present and give talks on the clinical trial within the University and at scientific and collaborator meetings.
  • Ensure the clinical research is undertaken according to applicable standards, policies, procedures, frameworks
  • and legislation.
  • Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.

Required Knowledge, Skills, Qualifications, Experience

  • Higher degree in a relevant biomedical or associated subject, or degree (or equivalent) with practical experience in clinical research relevant to research or teaching area.
  • In depth understanding of clinical research and trial management methodology and proven ability to apply these to the development, testing and implementation of trial management procedures.
  • Experience and understanding of techniques for the management of medical research information. For example, data coding, entry validation and reporting, automating procedures.
  • Experience in the design, maintenance and interrogation of complex relational databases.
  • Experience of using statistics packages (e.g. SPSS, SAD) to perform statistical tests to analyse and manage trial data.
  • Proven administrative and project management skills.
  • Ability to work on own initiative and solve problems.
  • Ability under management guidance to decide how to organise the work of a team, for example, Trial Administrator and Data Analyst.
  • Effective communication, negotiation, presentation and interpersonal skills.
  • Critical and intelligent attention to detail and high standard of accuracy.
  • Ability to meet the travel needs of the post.
  • Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.

Dimensions

The role may under management guidance oversee a Trial Administrator and Data Analyst, and will coordinate and support the trial management group, oversight groups and involved organisations. The role will coordinate one or more designated clinical trials (each typically 3 to 10 years duration), at a number of clinical sites.

Planning and organising

Responsibility for a trial will be held by the relevant Trial Management Team Leader with the day to day management of the Trial Coordinator by the Team Leader or Senior Trial Co coordinator. Trials are typically between 3 and 10 years duration. They follow a standard path through set up, recruitment, follow up, analysis, closure and archiving. The Trial Coordinator’s role varies according to the stage of the trial. The Trial Coordinator will plan and organise their workload and, if applicable, that of Trial Administrator and Data Manager.

Major deadlines of the trial (e.g. generation of specific reports) will be defined at the set up stage and remain constant throughout the trial. The Trial Coordinator will need to be reactive, because problems (e.g. safety issues) and queries from sites and/or patients often arise with very short notice, and frequently need to be dealt with quickly. Hence the role holder must be highly organised, reprioritise workload at very short notice, while still meeting regulatory deadlines.

Problem solving and decision making

The role works independently, addressing day to day problems (e.g. non clinical protocol queries) within trial protocol without reference to others. Judgement must be used to decide when queries need to be forwarded onto a clinician (safety or treatment queries) or a more senior member of staff (e.g. non-compliance with the protocol).

Internal and external relationships

The role is a key co-ordination role, setting, maintaining and communicating prescribed trial protocols with trial stakeholders, including staff at participating clinical sites, clinicians, senior members of the trial management team.

 

Further particulars can be found here

Informal enquiries to Ryan Ottridge, email: r.ottridge@bham.ac.uk

View our staff values and behaviours here

 

We believe there is no such thing as a ‘typical’ member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is a key part of our strategyYou can find out more about our work to create a fairer university for everyone on our website.

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