• Job Description

  Req#: 3818

  Position Details

  Institute of Applied Health Research, College of Medical and Dental Sciences

  Location: University of Birmingham, Edgbaston, Birmingham UK

  Full time starting salary is normally in the range £28,397 to £30,210, with potential progression once in post to £33,938

  Grade: 5

  Full Time, Fixed Term contract up to December 2024

  Closing date: 10th March 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 Senior Data Manager is responsible for the administration and collection of clinical research data for one or more trial protocols. They provide secretariat services to multi-disciplinary collaborative research group(s) engaged in clinical trials designed to improve the treatment and care of patients. Post holders work closely with the Trial Manager, ensuring the smooth process of trial administration, whilst providing support to colleagues, both inside and outside the unit, and give day to day operational guidance to Data Manager.

  Main Duties

  • Ensure smooth day-to day running of the study/trial protocol and data collection. This will involve the post holder ensuring they have a good understanding of how the general concepts underlying the design, conduct and analysis of clinical trials apply to routine trial management procedures and also how the clinical background and specific research questions being addressed applies to trial administration and data management.
  • Responsible for ensuring that trial data set(s) are complete, accurate and up to date. This will be achieved by running queries to interrogate trial databases and performing regular, systematic checks of information on the data base(s) and taking steps to correct any missing, contradictory or incorrect data. In addition the post holder will produce reports and lists on both a regular and ad-hoc basis.
  • Maintain research & administrative databases to produce clean data sets for statistical analysis. This will involve the management of medical data and operation of complex data base and information systems in order to code and abstract medical data and routine data entry.
  • Record and code incoming forms etc, checking for inconsistencies, violations and unusual or adverse events. Maintain and circulate coding lists under the guidance of the statistician, Manager and Programmer.
  • Offer initial guidance on interpretation and the development of new codes for non-routine and ad hoc data.
  • Test data entry, validation and report generation applications (i.e. confirming proper functioning of the trial database systems), reporting errors and suggesting modifications as appropriate. This will also involve creating and testing ad hoc data bases, forms and report generation.
  • Trial management includes general clerical duties by organising collaborative group meetings, handling petty cash, day to day distribution of trial materials, and drug supplies required by external centres.
  • Preparation and distribution of study documentation and publicity material for the Trial Working Group.
  • Conduct literature searches, using initiative to find missing or inaccurate references and to screen suitable papers. Maintain bibliographic databases by entering data, run duplicate checks and produce reference lists.
  • Develop and document the standard operating procedures applicable to the work of the post, under the guidance of the Trial Manager. Train others in their use.
  • Continue to develop and expand trial management skills and experience.
  • Will cover for the trial manager/ project leader and help supervise junior team members. Assist in the formulation of necessary guidelines.
  • 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, 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

  • A degree (or equivalent) in a relevant biomedical or associated subject, and be able to demonstrate relevant work experience e.g. in clinical trial management or as a clinical research nurse.
  • An aptitude for large and/ or more complex relational databases e.g. MS Access or SQL Server, including query/report writing and a full range of data verification, cleaning techniques.
  • Experience of using statistics packages such as SPSS, Minitab, BMDP or SAS.
  • Understanding of medical terminology and experience in interpreting and coding medical data.
  • Excellent all-round office management and clerical skills must include computing and office automation skills (e.g. email, word processing & document layout, the use of mail merge etc).
  • Must demonstrate a critical and intelligent attention to detail.
  • High standards of accuracy and apply a sound knowledge of the research framework to the work.
  • Aptitude for learning and applying new skills to ensure effective support and where necessary cover for the Trial Manager in order to help supervise junior team members.
  • Experience of conducting literature or internet searches, finding missing or inaccurate information, and maintenance of bibliographic databases.
  • Ability to interact as a team member, as well as working independently, deciding own short-term priorities and timetabling of tasks to meet agreed deadlines.
  • Good communication skills and an excellent telephone manner.
  • Maintains regular contact with professional research staff and members of the collaborating group. Handles routine communications (on own initiative) with the clinical investigators, research support staff and others in external centres for the collection of data and resolution of queries.
  • Ability to identify potential problems, applying previous experience of general processes and procedures to take decisions.
  • Work to develop and improve working practices under the Trial Manager’s guidance.
  • 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

  The Senior Data Manager is responsible to the Clinical Trial Manager and Trial Team Leader, and may supervise one or more Data Managers within that team.

  Planning and Organising

  Senior Data Managers are expected to follow Standard Operating procedures. They must be able to work independently and prioritise their own workload but will have access to guidance and support from other members of staff, (Senior) Trial Manager and Trial Management Team leader.

  Problem Solving and decision making

  … without reference to others

  • Senior Data Managers would be expected to solve most day to day trial related administrative problems without reference to others. For example if a research nurse does not understand from the protocol when patients should be seen the Senior Data Manager
  • Effectively deal with complex queries from Doctors, Nurses and other clinical staff
  • Proactively identifying missing data or any inconsistencies in the data received and resolving any anomalies encountered

  … after consulting others

  • Senior Data Managers would be expected to consult with the Trial Manager for resolution of ad hoc or complex trial related problems. For example offering guidance regarding Serious Adverse Event Recording
  • Able to draft promotional material to be included in newsletters under the guidance of the Trial Manager.
  • Able to identify the actions required in order to scope out a new trial question/piece of research

  … or that would be referred to someone else

  • Problems of a clinical nature should be referred to the Chief Investigator of the trial unless that responsibility has been delegated to another individual. For example a query regarding dose modification.
  • 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.
  • Assessing the impact of new trial legislation on existing processes – interpretation would be conducted by the Unit Coordinator and the required changes would then be incorporated into existing SOPs by the Senior Data Manager.

  Internal and External relationships

  Trial Manager, Trial Statisticians, Programmers, Research Nurses working on the trial – Smooth running of the trial during all the phases of the trial life cycle. Ability to effectively liaise with all members of the trial team in order to design and implement infrastructure necessary to run a successful trial

  Collaborating clinicians and nurses on own trial – Contact by phone, email and letter to resolve data queries. Need to be precise and clear regarding nature of query and action needed, working knowledge of data protection requirements. Ability to build a rapport with external contacts in order to effectively promote the trial and to maintain trial momentum

  Professors and Consultants and other medical personnel – Excellent communication and presentation skills

  Patients – Must be able to communicate with patients, appropriately, referring all queries of a clinical nature to the Trial Manager or Lead Clinician

  Suppliers – Be able to effectively negotiate with suppliers

  Further particulars can be found here
  
  Informal enquiries to Evans Asamane, email: e.a.asamane@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 everyone on our website .

• About the company

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

Notice