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Clinical Trials Data Specialist (XN06)
| Posting date: | 18 September 2024 |
|---|---|
| Salary: | £37,338.00 to £44,962.00 per year |
| Additional salary information: | £37338.00 - £44962.00 a year |
| Hours: | Full time |
| Closing date: | 14 October 2024 |
| Location: | Leeds, LS1 3EX |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9298-DRI-0169 |
Summary
We are seeking a Clinical Trials Data Specialist to join our clinical trials team, which is part of the NIHR Leeds Biomedical Research Centre (Leeds BRC), to contribute to research within Work stream 2 (SpA Prevention) and R&I Spondyloarthritis Research Portfolio. We are looking for candidates with demonstrable experience of clinical trials data management in an NHS Trust, University, pharmaceutical company or CRO. In this role, you will be expected to work closely with coordinators, statisticians and programmers and to liaise with medical staff involved in spondyloarthritis trials. The LBRC Work stream 2 works on a wide variety of clinical trials and translational studies in the field of musculoskeletal diseases. The clinical trials data specialist works across multiple teams and projects. If you enjoy learning, are enthusiastic about data management and have great attention to detail, read on, this post may be for you. PRINCIPLE DUTIES AND AREAS OF RESPONSIBILITY The data specialist will lead data management activities for allocated trials from set-up through to database lock ensure database and documentation are delivered on time and in line with regulatory guidance, Good Clinical Practice and SOPs produce or oversee database and CRF design specifications and testing, ensuring databases are fit for purpose work closely with the trial management team, in particular programmers, statisticians, coordinators to deliver all aspects of the data management project in line with agreed timelines actively participate in and lead allocated quality and improvement initiatives related to data management train junior staff and participating site personnel provide data management guidance to members of staff of all levels who not familiar with data management principles may line manage junior staff actively participate in and lead allocated quality and improvement initiatives related to data management train junior staff and participating site personnel provide data management guidance to members of staff of all levels who not familiar with data management principles may line manage junior staff We would particularly welcome candidates with experience of REDCap and/or MACRO or other eCRF data collection systems and programming skills. Clinical trial databases and clinical trial data management To produce and maintain design specifications for data capture tools and validations To develop and/or provide advice on the specifications for any other databases or systems required for the capture or transfer of clinical trials data or samples To test or oversee testing of clinical trials databases and other data capture tools to appropriate standards Liaise with LBRC IT team for the set-up, running and successful delivery of the project portfolio within LBRC WS2 and LTHT Spondyloarthritis Research Portfolio To perform and oversee data cleaning, verification, and validation. To develop Data management plans, CRF completion guidelines and other manuals In collaboration with the programming team, to contribute to the development of data query programmes that extract information from the designated datasets as required for reporting or cleaning purposes. To actively participate in working groups and meetings as a data management representative and feedback relevant discussions and decisions to the department. Sample management To design specifications, testing and maintenance of sample tracking tools To enter sample tracking information, as required. Project management To support the development of project plans for the implementation of databases and data management activity across the Leeds BRC and SpA Research Portfolio and be fully accountable for the subsequent data management elements of the project To maintain and develop data systems, collating information from multiple sources and research sites across the UK prioritising and coordinating a response To be the Data management representative on Trial management groups/Steering Committees, as appropriate To liaise with Leeds BRC and SpA Research Portfolio Senior Management team and researchers in developing strong relationships with them to ensure key project milestones are delivered on time Presenting findings based on study activity and performance, formulating appropriate action plans To quickly identify potential problems and provide solutions to ensure that the project remains on time Determine and escalate data quality issues as required, direct junior staff in response to findings To ensure that training and support is provided to clinical and academic colleagues to ensure that the data capture tools that have been developed can be fully implemented Collects and quality checks data from multiple formal research programs on a daily basis, feeding back findings to the rest of the delivery team. To assist Senior management in implementation and reporting of suitable data management metrics Compliance (Procedures, Quality Assurance, audit, reporting and maintenance of existing databases) To maintain documentation of databases and data management plans to meet regulatory standards in line with relevant Good Clinical Practice requirements, guidance, as well as UK clinical trials regulations and Sponsor SOPs. Provide input into the development of any new Standard Operating Processes and Procedures relating to data management To assist the programming team in optimisation of data capture tools, methods and documentation across the Leeds BRC and R&I SpA Portfolio studies To assist Trial coordinator in coordination activities, as required, such as remote and central monitoring To participate in audits and inspections for allocated trials. Assist the team in development and implementation of corrective and preventive action plans. Personnel management & Training To 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. This may include provision of advice and guidance to non-data managers (e.g. Trial Coordinators) involved in data management activities. To take part in the data management induction of new members of staff coming into Leeds BRC and SpA teams To assist in the training of participating sites, in particular with respect to site initiations and the roll-out of electronic Case Report Forms. To develop and review training materials for data managers The post-holder will be educated to degree level or equivalent or be able to demonstrate relevant experience commensurate with this post. They would be expected to have experience of working in an organisation which includes interaction with multiple departments or organisations. The post holder will be expected to show a thorough understanding of all legal requirements related to trials and must be familiar with GCP/ICH guidelines and the Declaration of Helsinki. The post requires evidence of relevant experience of Clinical Trials co-ordination and advanced data management skills. Excellent communication skills and the ability to provide and receive complex information in relation to study design are essential for this role. Excellent organisational, negotiation and presentation skills are essential, as well as the ability to work on their own initiative and as a team player.