Senior Clinical Research Data Manager

Job description

Job responsibilities

Key areas of responsibilityClinical data collection and management

• 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.

Site coordination, support and training

• Act as a principal operational contact for participating sites, developing effective working relationships with NHS Haemophilia Centre Medical Directors, Research Nurses, Data Managers and other relevant staff.
• 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.

Research governance, safety and quality assurance

• Apply a sound working knowledge of UK research governance requirements, including HRA and Research Ethics Committee requirements, Good Clinical Practice and sponsor responsibilities, to all relevant data-management activities.
• 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.

Service development and team responsibilities

 

• 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.

Person Specification

Qualifications

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

• Relevant postgraduate qualification or formal training in clinical research or data management

Physical and other requirements

• Able and willing to travel to external meetings and participating sites when required, with reasonable adjustments where necessary.

Knowledge

• 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.

• 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.

Experience

• 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.

• 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.

Skills and abilities

• 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.

• Experience of electronic data-capture or registry systems, advanced Excel, or data reporting and visualisation.

Personal attributes

• 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.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

UKHCDO

Address

UKHCDO Ltd

UKHCDO

Suite 1, 2nd Floor of Anchorage One,

Salford Quays

Greater Manchester

M50 3YJ

United Kingdom

Employer's website

http://www.ukhcdo.org/about-us/