• Job Description

  Req#: 4431

  Position Details

  Birmingham Clinical Trials Unit, College of Medical and Dental Sciences

  Location: University of Birmingham, Edgbaston, Birmingham UK

  Full time starting salary is normally in the range £25,866 to £27,518, with potential progression once in post to £30,820

  Grade: 4

  Full Time, Fixed Term contract up to March 2025

  Closing date: 16th April 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

  The Data Manager provides administrative support to the multi-disciplinary collaborative Trial research group(s) engaged in conducting trials.

  The Data Manager is responsible for the clinical research data set for one or more clinical trial(s) protocols which are designed to improve the treatment and care of patients. Day to day principal duties include obtaining, entering and cleaning data from participating sites.

  Main Duties

  • Be a fully trained member of the units’ randomisation team and take part in the regular 9-5 cover rota.
  • A key communications point for the research team and members of the collaborating group, answers initial enquiries and generally follows through to resolution. Handles routine communications with the clinical investigators, research support staff and others in external centres for data collection. Must keep confidentiality and represent the unit well at all times.
  • Ensure the smooth day-to day running of the study protocol and the data collection.
  • Record and code incoming forms etc., checking for inconsistencies, violations and unusual or adverse events. May be required to abstract or verify data from source medical records, possibly involving visits to centres. Maintain and apply coding lists under the guidance of the Statistician, Trial Manager and Programmer.
  • Enter routine data into the various research & administrative databases. Enter non-routine or ad-hoc data (i.e. that requires more interpretation or development of new codes) under guidance.
  • Perform regular, systematic checks to validate and verify information on the data base(s) in order to produce a clean, accurate and complete data set for analysis. Identify and resolve any missing, incomplete or contradictory data. This typically involves sending standard letters or telephoning to outline the problem. Produce reports and lists on both a regular and ad-hoc basis.
  • Work with Programmer, Statistician and Trial Manager to test data entry, validation and report generation applications (i.e. confirming proper functioning of the trial database systems), reporting errors and suggesting modifications if appropriate. May create and test simple ad-hoc data bases, forms and report generation.
  • Provide secretarial support as required by the research team. Maintain stocks of supplies (both internally and at outlying centres) tracking on current version numbers. Assist in the organisation of collaborative group meetings and travel arrangements. May handle petty cash. Responsible for the day to day distribution of trial materials, and drug supplies required by external centres
  • Develop and document standard operating procedures for the work of the post, under the guidance of the Trial Manager. Help supervise and train junior team members, and check the work done by others.
  • Continue to develop and expand trial management skills and experience. Ongoing formal and on the job training to develop advanced computing and broader trial management skills.
  • Will help to cover for the Trial Manager /project leader within own areas of expertise or projects. Other duties appropriate to the band may be assigned to the post.
  • Other duties appropriate to the band may be assigned to the post.
  • Supports equality and values diversity, moderates own behaviour to avoid unfair discriminatory impact or bias on others.
  • 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.

  Required Knowledge, Skills, Qualifications, Experience

  • Educated to at least ‘A’ level, or other equivalent formal vocational qualification (e.g. HND or NVQ 4), or relevant work experience ideally gained in a medical or academic setting.
  • Experience of medical data coding, data entry and data validation techniques. Able to query and maintain computer databases (including Microsoft Access).
  • Strong all-round office management experience and possess secretarial skills that must include up-to date computing and office automation skills (e.g. email, excellent word processing, good document layout etc).
  • Must demonstrate a critical and intelligent attention to detail including high standards of accuracy.
  • Good communication skills and an excellent telephone manner.
  • A flexible and willing attitude to being part of a multidisciplinary team. Works well independently, with access to advice in deciding own short-term priorities and timetabling of tasks to meet agreed deadlines.
  • Aptitude for learning and applying new skills, and once trained have the ability to work independently to gather information or simply finding missing or inaccurate data.
  • A data manager should develop an understanding of the general underlying concepts of trial design, conduct and analysis.
  • Data Managers are expected to develop an understanding of and have the ability to follow complex data management and administration procedures including the operation and maintenance of complex computer database and information systems.
  • Ability to identify and break down potential problems using past experience and knowledge of good research practices. Work to develop and improve working procedures with coaching from colleagues and supervision from the Trial Manager e.g. to ensure consistent interpretation and coding of the data.
  • Understands the importance of equality and diversity in the workplace.
  • Ability to identify and respond to equality and diversity issues in line with relevant policies and procedures.

  Dimensions

  Staffing:

  Experience Data Managers may mentor and occasionally supervise the work of more junior Data Managers and other junior staff.

  Financial:

  Data Managers do not handle budgets but may be involved in ordering supplies for a trial.

  Customers:

  Data managers are typically responsible for managing data relating to one or more clinical trials; as such they can interact with a large number (>500) of external contacts from the NHS including but not limited to: Consultants level Oncologists, Surgeons, Haematologists etc; Research Nurses; Pharmacists; Radiologists; General Practitioners; and trial management staff. Data Managers also work closely with one or more Biostatisticians, (Senior) Trial Managers and Programmers within BCTU.

  Operational:

  Data Managers represent the unit and the wider university in a professional capacity at local, regional and national level, in relation to the clinical trials they are supporting. For example they may be the first point of contact for queries relating to a trial, they may be involved in manning registration desks at national meetings etc.

  Planning and Organising

  Data Managers are located within one of five trial management teams within the BCTU. Their day-to-day work is supervised by a Trial Manager, with line management support from the relevant Senior Trial Manager and Trial Management Team Leader. Data Managers are allocated to a project by the relevant Trial Management Team Leader.

  Data Managers are responsible for data management of one or more clinical trials; they are a fully trained member of the units’ randomisation team; and they provide administrative support for their trials. They are responsible for managing their own workload within their specified areas of responsibility on a day-to-day basis and under the direction and supervision of the Trial Manager. Data Managers working across trials, which may have similar deadlines, have to carefully prioritise their workload to ensure that deadlines are met.

  Problem Solving and decision making

  … without reference to others

  • Data Managers would be expected to solve most day-to-day data management and trial related administrative queries without reference to others. For example if a research nurse does not know when to complete a medical Case Report Form the Data Manager can advise.
  • Data Managers are expected to follow BCTU Standard Operating Procedures. Data Managers must be able to work independently and prioritise their own work load but will have access to guidance and support from other members of staff, the Trial Administrator, (Senior) Trial Manager and Trial Management Team Leader, as required.

  … after consulting others

  • Data Managers would be expected to consult with the Trial Manager when dealing with complex data management or administrative queries. For example how to code a new medical condition within the database.

  … or that would be referred to someone else

  • Problems related to patient safety, the protocol, or the conduct of the trial would be referred to the Trial Manager or another senior member of staff.
  • Problems of a clinical nature should be referred to the Chief Investigator of the trial unless that responsibility has been delegated to another individual.

  Internal and External relationships

  Trial Managers, Statisticians, Programmers

  • Ability to liaise with all members of the trial team(s) in order to create the necessary infrastructure to deliver a successful trial.

  Collaborating Health Care Professionals, Researchers and Administrative staff

  • Contact by telephone, email and letter for resolving data queries. Must be precise and clear regarding nature of query and action needed, understanding of and compliance with data protection requirements

  Patients

  • Contact by telephone and letter to request data per the protocol. Response to enquiries by telephone, letter or email.
  • Know when to refer queries/problems to other more appropriately experienced members of the trial team.

  Suppliers

  • Assist with negotiations with suppliers.

  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 strategy. You can find out more about our work to create a fairer university for everyone on our website .

• About the company

  The University of Birmingham is a public research university located in Edgbaston, Birmingham, United Kingdom.

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