Location: Salford Quays
Salary: £49,387- £56,515 per annum - Band 7
Contract: Full time, Permanent
About the Role:
The National Haemophilia Database (NHD) is the UK's national registry for people with inherited and acquired bleeding disorders, collecting clinical and treatment data from NHS haemophilia centres across the UK.
We are seeking an experienced Senior Clinical Research Data Manager to provide specialist data management and coordination for post-marketing studies, investigator-initiated studies and other approved research delivered through the NHD.
Working with clinicians, NHS haemophilia centres, researchers and external study partners, you will translate study protocols and research questions into practical data-collection requirements. This will include developing study-specific Case Report Forms (CRFs), database modules, worksheets, data management plans and completion guidance.
You will also be a key operational contact for participating centres, helping sites meet study requirements and ensuring research data are complete, accurate, timely and suitable for analysis and reporting.
The role covers three main areas:
Clinical research data management - developing study data-collection tools and processes and coordinating data review, cleaning, validation and query resolution.
Site coordination and training - supporting participating NHS centres and providing practical guidance and training on study requirements and data submission.
Research governance and quality - ensuring study data management meets applicable research governance, data protection, consent and quality-assurance requirements.You will join the established UKHCDO/NHD multidisciplinary team, working alongside data managers, data scientists, statisticians and clinicians, and with external partners including pharmaceutical companies and Clinical Research Organisations (CROs).
Key Responsibilities:
Clinical Research Data Management:
You will:
Lead the design, review, piloting and implementation of paper and electronic CRFs, worksheets and study-specific data-collection tools.
Translate study protocols, endpoints and research questions into proportionate, clinically meaningful data fields and collection processes.
Develop and maintain data management plans, data dictionaries, CRF completion guidance and associated documentation.
Coordinate the collection, entry and verification of clinical research data from participating sites.
Review data for completeness, consistency and accuracy, managing data cleaning and query resolution.
Monitor data quality, completeness, timeliness and site performance.
Support the development and maintenance of NHD databases and study-specific modules, recommending improvements to systems and processes.Site Coordination and Training:
You will act as a principal operational contact for participating centres, building effective relationships with Haemophilia Centre Medical Directors, Research Nurses, Data Managers and other clinical and research staff.
You will establish practical data-collection arrangements, provide training and guidance on study requirements and CRF completion, respond to operational and system queries, and work collaboratively with sites to overcome barriers to high-quality and timely data collection.
You will also liaise with external study partners and CROs, attend relevant study meetings and coordinate agreed actions.
Research Governance and Quality:
You will apply a sound working knowledge of UK research governance, HRA and Research Ethics Committee requirements, Good Clinical Practice (GCP) and sponsor responsibilities.
You will ensure appropriate compliance with UK GDPR, the Data Protection Act 2018 and NHS information-governance requirements, maintaining confidentiality and appropriate management of personal data.
You will support safety-reporting and quality-assurance processes and ensure study documentation is accurate, complete and appropriately version controlled.
You will also contribute to team meetings, procedures, policies and service improvements, using a proactive and practical approach to solving problems and improving clinical research data management.
About You:
We are looking for someone who combines strong clinical research data-management skills with the ability to work effectively with busy NHS clinical and research teams.
Essential Requirements
You will have:
A degree in life sciences, health sciences, data management or a related subject, or equivalent relevant professional experience.
Current Good Clinical Practice (GCP) training.
Substantial experience in clinical research, clinical data management or study coordination.
Experience designing and implementing paper or electronic Case Report Forms (CRFs), clinical research databases, worksheets and completion guidance.
Experience managing clinical research data, including data review, cleaning, query resolution and monitoring data completeness and timeliness.
Experience working directly with clinical or research sites to establish data-collection processes, resolve operational difficulties and improve data quality.
Experience working effectively within multidisciplinary teams and with internal and external stakeholders.
The ability to manage several concurrent studies, projects or data initiatives.
Strong written, verbal, presentation, training and interpersonal skills.What We Offer:
Competitive contributory pension scheme
27 days' annual leave, rising to 33 days, plus public holidays
Professional development support
Flexible working options
Employee Assistance Programme
Salary sacrifice scheme
Life assurance
Modern Salford Quays offices with parking and excellent transport linksPlease submit your CV and covering letter.
We also welcome applications from candidates with relevant experience in roles such as Senior Clinical Data Manager, Clinical Research Data Lead, Lead Clinical Data Coordinator, Clinical Registry Data Manager, Post-Marketing Surveillance Data Manager
Salary description
£49387.00 - £56515.00 per year