Job Overview
The post holder will work as part of a Governance team, providing comprehensive data management support to the Research and Development Department. They will lead the development of Electronic Data Capture (EDC) systems, oversee clinical trials database management, and ensure compliance with Good Clinical Practice (GCP), MHRA and UK data protection requirements.
Responsibilities
- Lead data management for clinical trials using REDCap, relational databases and SQL to design, build and validate compliant data systems and case report forms.
- Provide specialist advice to researchers on data collection, management and interpretation, supporting study design, statistical analysis and reporting for sponsors, data monitoring committees and research networks.
- Maintain Trial Master Files, develop SOPs, and resolve data quality issues in collaboration with study teams.
- Manage secure data storage and handling in line with UK GDPR, acting as the key contact for data queries and ensuring timely, accurate responses.
- Support study set‑up and delivery through training at Site Initiation Visits and promote GCP and correct data entry practices.
- Contribute to audit and inspection readiness, produce clear reports and data insights, and continuously improve data management processes.
- Build and maintain effective working relationships with other staff, departments, external agencies and sponsor companies.
- Attend multidisciplinary meetings to assist in identifying eligible patients for clinical trials and present information at staff group and department meetings.
- Respond to routine and ad hoc requests for information from staff within the CRF, sponsors and across the Trust.
- Respect the confidentiality of patient data and safeguard data in accordance with UK GDPR and the Data Protection Act 2018.
- Assist with new staff orientation programmes and identify personal training and development needs.
Qualifications – Education and Training
- Degree in a relevant subject (data science, statistics, computer science, life sciences) or equivalent experience with significant experience in clinical trial data management.
- Advanced knowledge of clinical data management systems such as REDCap, relational database design and SQL, supported by practical experience in database development, validation and regulatory compliance (GCP, MHRA).
- Postgraduate qualification in a relevant field (clinical research, biostatistics, data science) or equivalent specialist knowledge gained through experience, including statistical analysis and preparation of analysis‑ready datasets.
Qualifications – Skills and Ability
- Substantial analytical skills, able to demonstrate success across a wide range of disciplines and levels.
Qualifications – Experience
- Knowledge and experience of working with research contracts.
Benefits
- Competitive salary including a high‑cost area supplement.
- Membership of the NHS Pension Scheme.
- 24/7 independent counselling support.
- Career‑long learning and development opportunities.
- Excellent transport connections.
- Access to NHS and Blue Light discount schemes.
- Full support and training to develop your skills.
Equal Opportunities
Our commitment to equality, diversity and inclusion is at the heart of our organisational culture. We encourage applications from under‑represented candidates, including BAME and disabled individuals, and work towards a representative workforce that delivers quality, dignity and respect.
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