Senior Clinical Research Data Manager

• Lead the design, review, piloting and implementation of paper and electronic Case Report Forms (CRFs), worksheets and associated data-collection tools.
• Translate study protocols, endpoints and research questions into clear, proportionate and clinically meaningful data fields and collection processes.
• Develop and maintain data management plans, data dictionaries, CRF completion guidance, study-specific procedures, templates and other supporting documentation.
• Coordinate the timely collection, electronic entry and verification of clinical data from participating sites, including data required for regulated post-marketing surveillance studies.
• Review submitted data for completeness, consistency and accuracy, raising and resolving data queries and following up missing or incomplete information.
• Monitor data entry, data cleaning, query resolution and site performance, escalating significant or persistent concerns to the NHD Manager.
• Support the development and continued maintenance of NHD databases and study-specific modules, including the Gene Therapy Database.
• Recommend improvements to CRFs, databases and data-management processes in response to user feedback, data-quality findings and changing study requirements.

• Lead the design, review, piloting and implementation of paper and electronic Case Report Forms (CRFs), worksheets and associated data-collection tools.
• Translate study protocols, endpoints and research questions into clear, proportionate and clinically meaningful data fields and collection processes.
• Develop and maintain data management plans, data dictionaries, CRF completion guidance, study-specific procedures, templates and other supporting documentation.
• Coordinate the timely collection, electronic entry and verification of clinical data from participating sites, including data required for regulated post-marketing surveillance studies.
• Review submitted data for completeness, consistency and accuracy, raising and resolving data queries and following up missing or incomplete information.
• Monitor data entry, data cleaning, query resolution and site performance, escalating significant or persistent concerns to the NHD Manager.
• Support the development and continued maintenance of NHD databases and study-specific modules, including the Gene Therapy Database.
• Recommend improvements to CRFs, databases and data-management processes in response to user feedback, data-quality findings and changing study requirements.

• Liaise with external stakeholders, including CRO representatives, to support the effective delivery of NHD studies.
• Establish practical data-collection arrangements with participating sites, taking account of local clinical workflows, staffing and source-data availability.
• Coordinate confirmation that the necessary approvals, agreements, training and consent arrangements are in place before study data collection begins.
• Provide training, guidance and practical support to site teams on study requirements, CRF completion and the use of relevant NHD databases.
• Respond promptly to operational and system-related queries and ensure an efficient flow of information between participating sites, the NHD team and external study partners.
• Identify barriers to data collection and work collaboratively with sites to improve the completeness, quality and timeliness of data submission.
• Contribute to the implementation of new database consent processes, including coordinating and delivering training to NHS haemophilia staff on their purpose and use.
• Attend relevant study and gene therapy meetings, provide data and site updates, prepare concise minutes where required and coordinate the completion of agreed actions.

• Ensure that data-management practices comply with UK GDPR, the Data Protection Act 2018, NHS information-governance requirements and relevant UKHCDO/NHD policies.
• Maintain confidentiality and ensure that documents and data shared externally are appropriately anonymised, pseudonymised or redacted before release.
• Support agreed safety-reporting processes, including the identification, documentation, reconciliation and timely onward reporting of adverse-event information to the responsible study, sponsor or pharmacovigilance teams.
• Contribute to quality-assurance and audit programmes and support audit and inspection-readiness activities relating to study data and data governance.
• Maintain accurate, complete and appropriately version-controlled study and data-management documentation.
• Keep up to date with relevant changes in research governance, data protection and information-governance requirements, escalating any implications to the NHD Manager.

• Contribute to team meetings by providing updates on data quality, site performance, study delivery and emerging operational issues.
• Contribute to the development and review of standard operating procedures, policies, guidance and data-management processes.
• Apply a proactive and practical problem-solving approach to service delivery and contribute positively to improvement and change.
• Establish and maintain effective communication within the UKHCDO/NHD team and with participating centres and partner organisations.
• Demonstrate effective written, verbal, presentation and training skills appropriate to a range of professional audiences.
• Work flexibly where reasonably required to meet study and service needs.
• Undertake other responsibilities commensurate with the grade and contribute to emerging areas of work as UKHCDO/NHD priorities evolve.

Essential

• Degree in life sciences health sciences data management or a related subject or equivalent relevant professional experience
• Current Good Clinical Practice GCP training

Essential

• Detailed working knowledge of clinical research, Good Clinical Practice, UK research governance and the relevant regulatory framework.
• Working knowledge of UK GDPR, the Data Protection Act 2018, confidentiality and information-governance requirements for clinical research data.
• Understanding of the principles of CRF design, data validation, data quality, version control and audit trails.

Desirable

• Knowledge of bleeding disorders and their treatment.
• Knowledge of gene therapy and associated long-term follow-up requirements.
• Knowledge of post-marketing surveillance studies, registries or real-world evidence collection.

Essential

• Substantial experience in clinical research, clinical data management or study coordination
• Experience of designing and implementing paper or electronic Case Report Forms (CRFs), clinical research databases, worksheets and associated completion guidance.
• Experience of managing clinical research data, including data review, cleaning, query resolution and monitoring completeness and timeliness.
• Experience of working directly with clinical or research sites to establish data-collection processes, resolve operational difficulties and improve data quality.
• Experience of working effectively within multidisciplinary teams and with internal and external stakeholders.
• Experience of managing several concurrent studies, projects or data initiatives.

Desirable

• Experience of multicentre clinical trials, registries or post-marketing studies.
• Experience in the NHS or an equivalent healthcare setting, or working with pharmaceutical companies, CROs or study sponsors.

Essential

• Ability to interpret a study protocol or research question and develop practical, proportionate data-collection tools and processes.
• Strong organisational and prioritisation skills, with the ability to manage concurrent workstreams autonomously and meet deadlines.
• Excellent written and verbal communication skills, including producing guidance, delivering training and giving presentations.
• Ability to build effective relationships with clinical sites and resolve data-quality or operational issues collaboratively.
• Competence in Microsoft Office and relevant clinical research or data-management systems.

Essential

• Self-directed, highly motivated and able to work with limited supervision
• Flexible, positive and proactive approach to work.
• Comfortable working independently and collaboratively as part of a multidisciplinary team.
• Commitment to accuracy, confidentiality and high-quality clinical research data.
• Willingness to contribute to the continuing development of the role as NHD priorities evolve.