The post holder would also be supporting with the preparation and distribution of home testing DBS kits to participants and stock requests for clinics in accordance with the ELSA study working procedures, as well as performing quality control checks on documents and kits as necessary.

Role Summary

The Senior Data Manager is responsible for the administration and collection of clinical research data for one or more study protocols. They provide secretariat services to multi-disciplinary collaborative research group(s) engaged in studies designed to improve the treatment and care of patients. Post holders work closely with the Senior Study Coordinator, Study Coordinator and the Database Developer, ensuring the smooth process of study administration, whilst providing support to colleagues, both inside and outside the team.

The post holder for this role will be primarily supporting a range of type 1 diabetes projects. An active research passport and a knowledge of or experience of working on diabetes studies would be advantageous.

Main Duties

• Ensure smooth day-to-day running of the study protocol and data collection. This will involve the postholder ensuring they have a good understanding of how the general concepts underlying the design, conduct and analysis of studies apply to routine 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 study 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 database(s) and taking steps to correct any missing, contradictory or incorrect data. In addition, the postholder will produce reports and lists on both a regular and ad-hoc basis and manage users within these systems.
• Maintain research & administrative databases to produce clean data sets for statistical analysis. This will involve the management of medical data and operation of complex databases 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 and Manager/Study Co-ordinator.
• 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 databases, forms and report generation.
• Study management includes general clerical duties by organising collaborative group meetings, acting as a point of contact for external sites for study enquiries, handling petty cash, day-to-day distribution of study materials, and drug supplies required by external centres.
• Preparation and distribution of study documentation and publicity material for the study
• 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 study coordinator. Train others in their use.
• Continue to develop and expand study management skills and experience.
• Will cover for the study coordinator / project leader and help supervise junior team members. Assist in the formulation of necessary guidelines and working instructions.
• 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 1998, 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, or be able to demonstrate relevant work experience e.g. in study/clinical trial management or as a clinical research nurse.
• An aptitude for large and/or more complex relational databases e.g. SQL Server, REDCap 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 Study Co-ordinator 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 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.
• Ability to understand policy and procedures and how to apply these.
• Understands the importance of equality and diversity in the workplace.
• Ability to identify and respond to equality and diversity issues in line with relevant university policies and procedures relating to equality and diversity.
• Other relevant criteria from our equality and diversity knowledge, skills and experience document [here](https://bham.sharepoint.com/:w:/r/