Overview
As Data Manager at Newcastle University’s Clinical Trials Unit, you will oversee data capture, management and quality across multiple clinical trials to support robust analyses and regulatory compliance. You will collaborate with Chief Investigators, trial teams and statisticians to design databases, randomisation systems and documentation that ensure data integrity. The role emphasizes proactive data cleaning, risk-based quality controls and timely reporting to stakeholders. You’ll contribute to process improvements, training and SOP development, making a tangible impact on trial outcomes and patient care. This opportunity combines scientific rigor with cross-functional collaboration in a高‑
Pay / Benefits
- generous holiday package
- great pension schemes
- health and wellbeing initiatives
- flexible working arrangements
- opportunity for home/office blended work arrangement
- salary progression to 46,970 per annum
Responsibilities
- Design, develop, test and maintain databases and data capture systems for clinical trials per SOPs using CDMS packages (e.g., Red Pill, ENNOV, RedCAP)
- Design, develop, test and maintain randomisation systems for clinical trials using systems (e.g., Sealed Envelope, ENNOV)
- Collaborate with trial management to shape data collection forms
- Oversee collection and entry of data from centers into databases or data tools
- Ensure accurate, complete and timely data entry and routine data cleaning/quality controls
- Prepare data for analysis, including coding (e.g., MedDRA)
- Plan data collection systems with CI and broader research team
- Attend meetings as data management expert and build strong stakeholder relationships
- Lead data management plans, validation plans and related documentation
- Provide data and metrics for monitoring, progress reporting to funders/ethics/trial committees
- Ensure documentation adheres to legislation, guidance and SOPs; ensure GMP/GCP and GDPR compliance
- Ensure secure data backups and assist in preparing publications/presentations
- Deliver training on data capture systems and develop user manuals
- Contribute to SOP/policy writing and quality improvement initiatives
- Plan and organize own workload and supervise others when required
- Maintain good working relationships with partners and collaborators
- Other duties appropriate to the grade, including potential line management
- Travel occasionally for meetings and training
Key requirements
- High literacy and numeracy
- Ability to prioritise, work independently and in teams
- Strong organisational and administrative skills
- Excellent communication and use of initiative in complex environments
- Knowledge of good data management principles
- Understanding regulatory governance for clinical trials in the UK
- Awareness of data protection and confidentiality requirements
- Experience in database design and data management, checking and reporting
- Proficiency with Microsoft Office
- Experience in setting up and managing research data management systems
- Data handling and reporting capabilities
- Ability to develop reports and raise queries (e.g., web-based CRFs)
- Excellent IT skills
- Attention to detail
- Excellent interpersonal skills
- Strong written and verbal communication
- Statistical software (desirable)
- SQL programming (desirable)
- Clinical Data Management Systems (MACRO, ENNOV, Red Pill) (desirable)
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