Trial Manager - Institute of Applied Health Research - 103031 - Grade 6

Position Details

Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences

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 (minimum contract duration of 16 months)

Multiple posts available

Closing Date: 1st January 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

Background

The Birmingham Clinical Trials Unit (BCTU) is a leading national clinical trials unit (CTU) within the College of Medical & Dental Sciences at the University of Birmingham specialising in the design, conduct and analysis of definitive clinical trials and test evaluation studies, under the Directorship of Professor Katie Morris.

The Trial Manager will be a member of one or more trial working groups, responsible for the management and organisation of the trial(s) office for the conduct of large, clinical trial protocols and administration of the clinical collaborative groups.

Main Duties

• Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and quality standards of the Clinical Trials Unit and that appropriate records and audit trails are maintained.
• Ensure that the trial complies with current regulatory reporting requirements (e.g. of adverse events) to the relevant bodies e.g. competent authorities, ethics committees, investigators etc.
• Set up clinical sites, prepare ethics committee and regulatory submissions and ensure that the staff at participating sites understand and are able to comply with the protocol.
• Monitor progress of each site and take appropriate action to ensure good recruitment; compliance with the protocol, and the quality and timeliness of the data collection. Use initiative to tackle any practical difficulties reported by sites i.e. those which affect recruitment, protocol or Good Clinical Practice compliance or patient safety. Conduct initiation, problem solving, monitoring, quality assurance/audit visits as required.
• The Trial Manager may contribute to the design, analysis, publication and presentation of the research. This may involve writing research grant applications; contributing to the design, development and feasibility/testing of protocols; case report forms; coding lists, and databases. Also, writing abstracts; designing posters. and contributing to journal articles.
• Responsible for the collection, processing and secure storage of the study documentation.
• Apply an in-depth understanding of the clinical research to ensure that the methods used to implement and conduct the protocol are consistent with answering the key research questions reliably. This will involve developing work plans to translate the major methodological requirements into practice. Plans must consider the wider implications i.e. to colleagues; policies of the Clinical Trial Unit; Good Clinical Practice; quality management; feasibility; costs, and deadlines.
• Organise and administer the external collaborative group. Identify, recruit and support participating sites. Provide regular feedback on the progress of the trial and encourage sites to meet recruitment targets. Plan and organise mailshots, newsletters and collaborator or investigator meetings. Maintain the trial website.
• Responsible for ensuring that the collection of data during the course of the trial is conducted so as to provide a complete, accurate and up to date trial data set(s) for analysis according to agreed deadlines. Train and supervise other staff (internal and external) involved in data management in the rules and procedures to be used, explaining the reasons/ principles behind them.
• Enter data onto the computer databases and perform regular systematic checks of information held on the trial database(s). Decide what steps need to be taken to correct any missing, contradictory or incorrect data and ensure that these problems are followed through to a satisfactory conclusion within a reasonable timescale. Monitor for systematic or serious errors and inconsistencies, breaking problems down to identify their cause in order to take action to improve working systems and prevent recurrence.
• Develop and document guidance notes and procedures for the conduct of the trial and ensure other members of staff are fully trained to understand and follow them. Create trial management tools including forms and databases.
• Prepare trial reports as required for example progress reports required by the Clinical Trail Unit management and the various trial steering and data monitoring committees, funding bodies or sponsors. Maintain the Clinical Trial Unit’s Central Administrative Database.
• Co-ordinate and support the activities of the trial management group, steering and data monitoring committees. Represent the Clinical Trial Unit’s interests and policies effectively at this level and report back to management.
• Key member of the trial management group contributing to the content, type and frequency of the case report forms to collect the information required to answer the research questions reliably and efficiently. Designing case report forms etc. to be as attractive and easy to use thus promoting error free data return. In discussion with clinical investigators decide the rules and procedures that will be used for coding, interpretation, entry and checking of the data.
• Record and code incoming forms and/or abstract from source records for data entry, checking for inconsistencies, violations and unusual or adverse events. Where necessary, agree new or changed rules, codes and procedures for the entry of non-routine or ad-hoc data with the trial management group. Maintain and circulate coding lists and inform other trial management staff of changes.
• Work with the trial statistician, performing preliminary and routine data analysis.
• Contribute to the work of the trial management team, supporting the Senior Trial Manager and/or Trial Team Manager, lead statistician and principal clinical investigators in the development and conduct of the team’s entire portfolio of research. Represent team on Clinical Trial Unit committees e.g. web committee, publicity committee etc.
• Contribute to the Clinical Trial Unit’s Quality Management System.
• Keep up to date with current research literature and developments in both the professional field and the clinical site speciality. Maintain relevant bibliographies by regular literature searches and critical review. Developing and publishing innovative approaches to improving trial methodology is encouraged.
• Present and give talks on the research (i.e. about the clinical trial and trial methodology) both internally and at major scientific / collaborators meetings. Managers may have some lecturing and teaching duties within the School and on the various clinical trial professional development courses.
• Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
• Support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, General Data Protection Regulation (GDPR), Data Protection Act 2018, Human Tissue Act), the Research Governance Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.

Person Specification

• Degree in a relevant Biomedical or associated subject, or’ experience within clinical research.
• An 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.
• The ideal candidate would have significant experience of running trials in a surgical and/or international setting.
• The successful candidate may be required to travel internationally as part of the role.
• Excellent office management and clerical skills that include word processing & document layout.
• Experience and understanding of techniques for the management of medical research information e.g. data coding, entry validation and reporting.
• Ability to develop automated office procedures and to manage complex relational computer databases.
• Experience in the design, maintenance and interrogation of complex relational databases (MS Access or SQL Server preferred).
• Experience of using statistics packages such as SPSS and SAS e.g. to perform appropriate statistical tests and procedures for routine analysis and management of the trial data. Proven administrative and project management skills.
• Able to work on own initiative and problem solve.
• Effective communication, negotiation, presentation and inter-personal skills.
• Ability to demonstrate critical and intelligent attention to detail and high standards of accuracy. Ability to meet the travel needs of the post which includes travel in the Birmingham area and further afield on occasions.
• 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

Staffing: The Trial Manager may be supported by a Senior Data Manager (Grade 5) and/or Data Manager (Grade 4). Where such support is available the Trial Manager will assume supervisory responsibility for these staff members.

Financial: This would depend on the nature of the trial. Trial Managers are not responsible for the whole trial budget, but they may be delegated the task, for example monitoring running expenses (e.g. travel and site payments) against the predicted budget.

Trial Managers are not usually responsible for generating monies, but may assist the Trial Team Manager and/or Senior Trial Manager in writing part of a research grant application.

Customer: An important aspect of the post of Trial Manager is to build relationships with a range of customers, typically including: professors, consultants, nurses, pharmacists, and other medical professionals who may be members of one of the trial groups/committees or based at participating sites; other trials professionals e.g. statisticians, programmers, monitors; patients and patient representatives; the Sponsor representative; contracts officers, and suppliers.

Trial Managers can manage as many as 6 clinical trials, as such they can interact with a large number of external customers (this can be >500).

Operational: Clinical trials are highly regulated hence it is important that Trial Managers are able to comply with unit policy and procedure. Trial Managers are expected to make a contribution to the writing of Standard Operating Procedures for specific trial management related tasks. They are also expected to convey Clinical Trial Unit policy and procedure to both internal and external investigators.

Trial Managers represent the Clinical Trial Unit in a professional capacity at local, regional and national meetings and fund raising events.

Planning and organising

A Trial Manager is employed to co-ordinate one or more clinical trials, which contribute to the University’s research output.

Responsibility for a particular trial will be allocated by the relevant Trial Team Manager, with the day to day management of the Trial Manager being provided by the Trial Team Manager or a Senior Trial Manager. Trials are typically between 3 and 10 years duration. They follow a standard path through set-up, recruitment, follow up, analysis, closure and archiving, and the Trial Manager’s role will vary according to the stage of their trial(s).

The Trial Manager will need to plan and organise their own workload, and if applicable that of the Senior Data Manager and/or Data Manager. Major deadlines for the trial (e.g. generation of specific reports) are usually defined at the set-up stage and will remain relatively constant throughout the life time of the trial. However the Trial Manager will need to be reactive as problems and queries from sites and/or patients often arise with very short notice and quite frequently have to be dealt with immediately. Hence Trial Managers have to be very organised and able to reprioritise their workload at a moment’s notice while still meeting regulatory deadlines.

Problem solving and decision making

Trial Managers must be able to work independently and are expected to deal with day-to-day problems (e.g. non-clinical protocol queries) without reference to others. Trial Managers must be able to use sound judgment in deciding when queries need to be forwarded onto a clinician (for example safety or treatment queries) or a more senior member of staff (for example non-compliance with the protocol).

They are expected to follow the Clinical Trial Unit’s quality management system and comply with the protocol, the ethical and regulatory approvals for the trial, GCP, research governance guidelines and applicable regulations.

Internal and external relationships

Funding Bodies: Must be able to effectively communicate details of research proposal. Good negotiation skills are required.

Professors & Consultants: Excellent communication and presentation skills. Must be able to clearly explain scientific background, clinical, practical and financial aspects of research projects effectively.

Patients: Must be able to communicate with patients, answering queries they may have in a way appropriate to their level of understanding. Will take responsibility for writing Patient Information Sheets that must be easy for the layperson to understand and comply with current ethical guidelines.

Suppliers: Be able to effectively negotiate with suppliers.

Further particulars can be found here

Informal enquiries to Hayley Walton, email: h.l.walton@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. You can find out more about our work to create a fairer university for everyoneon our website.