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
1. 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.
2. 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.
3. 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.
4. 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.
5. Offer initial guidance on interpretation and the development of new codes for non-routine and ad hoc data.
6. Test data entry, validation and report generation applications (. 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.
7. 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.
8. Preparation and distribution of study documentation and publicity material for the Trial Working Group.
9. 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.
10. 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.
11. Continue to develop and expand trial management skills and experience.
12. Will cover for the trial manager/ project leader and help supervise junior team members. Assist in the formulation of necessary guidelines
13. Supports equality and values diversity, moderates own behaviour to avoid unfair discriminatory impact or bias on others.
14. 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
15. A degree (or equivalent) in a relevant biomedical or associated subject, and be able to demonstrate relevant work experience. in clinical trial management or as a clinical research nurse is desirable but not essential.
16. An aptitude for large and/ or more complex relational databases. MS Access or SQL Server, including query/report writing and a full range of data verification, cleaning techniques.
17. Experience of using statistics packages such as SPSS, Minitab, BMDP or SAS.
18. Understanding of medical terminology and experience in interpreting and coding medical data.
19. Excellent all-round office management and clerical skills must include computing and office automation skills (. email, word processing & document layout, the use of mail merge etc).
20. Must demonstrate a critical and intelligent attention to detail.
21. High standards of accuracy and apply a sound knowledge of the research framework to the work.
22. 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.
23. Experience of conducting literature or internet searches, finding missing or inaccurate information, and maintenance of bibliographic databases.
24. 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.
25. Good communication skills and an excellent telephone manner.
26. 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.
27. Ability to identify potential problems, applying previous experience of general processes and procedures to take decisions.
28. Work to develop and improve working practices under the Trial Manager’s guidance.
29. Understands the importance of equality and diversity in the workplace.
30. Ability to identify and respond to equality and diversity issues in line with relevant policies and procedures.