Senior Information Systems & Data Manager at Newcastle University

The Person

Knowledge, Skills and Experience 

• Substantial experience of leading, managing and working in teams, with excellent teamwork skills
• Experience in change management and process improvement
• Able to work independently, and to make decisions on complex matters
• Proven leadership skills in a multi-stakeholder environment
• Substantial relevant data management experience relating to interventional clinical trials
• Substantial recent experience of the requirements, design, development and build of databases related to clinical research including off the shelf CDMS tools (e.g. Ennov, Medidata, MACRO, Red Pill, RedCAP)
• Advanced and recent working knowledge in systems, and software that support data collection, storage, analysis, and reporting, along with strong skills in effective use of Microsoft office tools including Excel and Word
• Very good working knowledge of one or more statistics packages (e.g. STATA, SAS, SPSS, R, Minitab)
• Substantial experience of clinical data management across the full trial lifecycle, and oversight of all data management activities, including development of documentation, query management, programming, data validation and liaison with trial and study teams including production of reports
• Substantial experience of developing and documenting new data management processes, polices, and SOPs
• Experience in line managing, supervising, mentoring/coaching, and managing performance of staff
• Thorough understanding of information governance, the requirements for hosting NHS Digital data, and the regulatory framework for data protection and management including GDPR
• Demonstrable knowledge of the regulatory framework for clinical trials (Good Clinical Practice, EU Clinical Trials Directive)
• A proactive approach with excellent organisational skills, and the ability to prioritise workload effectively whilst working across multiple projects and teams concurrently
• Broad understanding of clinical trials methodology
• Proven analytical and problem-solving skills
• Effective project management skills, ideally for Data Management or clinical research

Desirable

• Experience of working in a University, Pharmaceutical Industry, or NHS environment
• An understanding of data collection in an NHS research environment
• Experience of managing data management staff

Attributes and Behaviour

• Excellent communication and interpersonal skills, with the ability to communicate and work effectively with staff at all levels
• Ability to motivate, negotiate and influence both individuals and teams
• Ability to handle sensitive and confidential issues and manage conflict effectively
• High degree of initiative, responsibility and self-motivation and a professional and proactive approach to problem solving
• Ability to define priorities and work flexibly and effectively under pressure to meet demanding (and sometimes conflicting) deadlines
• Willingness to learn new skills and procedures
• High levels of resilience
• Flexible team player willing to do what it takes to get the job done; adaptable and enjoys a challenge
• Excellent attention to detail
• Flexible approach to working
• Willingness to travel

Qualifications

• Degree in a relevant subject (a degree in a scientific, mathematical or statistical field is considered relevant) or equivalent significant professional experience