Clinical Trials Data Specialist

4 weeks ago

Leeds, Leeds, United Kingdom Leeds Teaching Hospitals Full time
Job Title: Clinical Trials Data Specialist

We are seeking a highly skilled Clinical Trials Data Specialist to join our team at Leeds Teaching Hospitals. As a key member of our clinical trials team, you will play a crucial role in contributing to research within the NIHR Leeds Biomedical Research Centre (Leeds BRC) and the SpA Research Portfolio.

Key Responsibilities:
  1. Lead data management activities for allocated trials from set-up through to database lock.
  2. Ensure database and documentation are delivered on time and in line with regulatory guidance, Good Clinical Practice, and SOPs.
  3. Design and oversee database and CRF design specifications and testing, ensuring databases are fit for purpose.
  4. Collaborate with the trial management team, programmers, statisticians, and coordinators to deliver all aspects of the data management project in line with agreed timelines.
  5. Participate in and lead allocated quality and improvement initiatives related to data management.
  6. Provide data management guidance to members of staff of all levels who are not familiar with data management principles.
  7. Develop and maintain design specifications for data capture tools and validations.
  8. Test or oversee testing of clinical trials databases and other data capture tools to appropriate standards.
  9. Liaise with the LBRC IT team for the set-up, running, and successful delivery of the project portfolio within the Leeds BRC and LTHT SpA Research Portfolio.
  10. Perform and oversee data cleaning, verification, and validation.
  11. Develop data management plans, CRF completion guidelines, and other manuals.
  12. Contribute to the development of data query programs that extract information from designated datasets as required for reporting or cleaning purposes.
  13. Participate in working groups and meetings as a data management representative and feedback relevant discussions and decisions to the department.
  14. Support the development of project plans for the implementation of databases and data management activity across the Leeds BRC and SpA Research Portfolio.
  15. Maintain and develop data systems, collating information from multiple sources and research sites across the UK, prioritizing and coordinating a response.
  16. Represent the data management team on Trial Management Groups/Steering Committees, as appropriate.
  17. Liaise with Leeds BRC and SpA Research Portfolio Senior Management team and researchers to ensure key project milestones are delivered on time.
  18. Present findings based on study activity and performance, formulating appropriate action plans.
  19. Identify potential problems and provide solutions to ensure that the project remains on time.
  20. Determine and escalate data quality issues as required, direct junior staff in response to findings.
  21. Ensure that training and support are provided to clinical and academic colleagues to ensure that the data capture tools that have been developed can be fully implemented.
  22. Collect and quality-check data from multiple formal research programs on a daily basis, feeding back findings to the rest of the delivery team.
  23. Assist Senior Management in implementation and reporting of suitable data management metrics.
  24. Maintain documentation of databases and data management plans to meet regulatory standards in line with relevant Good Clinical Practice requirements, guidance, and UK clinical trials regulations and Sponsor SOPs.
  25. Provide input into the development of any new Standard Operating Processes and Procedures relating to data management.
  26. Assist the programming team in optimizing data capture tools, methods, and documentation across the Leeds BRC and R&I SpA Portfolio studies.
  27. Assist Trial Coordinator in coordination activities, as required, such as remote and central monitoring.
  28. Participate in audits and inspections for allocated trials. Assist the team in development and implementation of corrective and preventive action plans.
  29. Train and mentor less experienced members of staff within own team and generally across the Leeds BRC and R&I SpA research teams in data management and data capture design.
  30. Take part in the data management induction of new members of staff coming into Leeds BRC and SpA teams.
  31. Assist in the training of participating sites, in particular with respect to site initiations and the roll-out of electronic Case Report Forms.
  32. Develop and review training materials for data managers.

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