Study Manager (Part Time, Fixed Term)

University of Cambridge; Cambridge; On-site; GBP 55,000 - 80,000; Full time

Job summary

University of Cambridge in Cambridge is seeking a proactive operations leader to head delivery of the NIHR-funded NeWTS programme's neonatal medical device clinical investigations. You will oversee multi-site studies from set-up to close-out, ensuring regulatory compliance, data integrity and timely delivery to support regulatory approval and adoption.

Working with NHS partners, academia and industry, you will manage governance, budgets and stakeholder engagement, driving continuous improvement

Job description

Join the NIHR-funded NeWTS programme to lead delivery of a portfolio of pioneering neonatal medical device clinical investigations. The University of Cambridge, Department of Paediatrics, NeWTS team is delivering a complex, high profile medical device development programme comprising multiple inter-related clinical investigations involving adults, neonates, NHS organisations, academic partners and commercial collaborators. The programme is central to generating the clinical and usability evidence required to support regulatory approval and adoption of the NeWTS device into routine clinical practice.

Working with Dr Kathryn Beardsall and partners across the NHS, academia and industry, the post holder will oversee study delivery from set-up to close-out and play a key role in bringing an innovative neonatal technology towards regulatory approval and clinical adoption.

Successful delivery of these investigations is critical to supporting regulatory approval and adoption of the NeWTS device into routine clinical practice.

The post holder will have a key role in the operational leadership and delivery of the NeWTS clinical investigation portfolio, which includes usability studies, clinical investigations and implementation research conducted across multiple sites and stakeholder groups. The role requires coordination of complex study activities, management of regulatory and governance processes, oversight of study performance and risk management, and engagement with internal and external stakeholders to ensure delivery of programme objectives.

Working closely with the Chief Investigator and wider programme team, the post holder will act as a central operational contact for collaborating organisations, NHS partners, regulatory authorities and industry stakeholders, providing oversight of study delivery from set-up through to close-out. The role will contribute to the development of systems, processes and partnerships that support high-quality, compliant and efficient delivery of the programme within agreed timelines, budgets and governance frameworks.

The post holder will provide operational leadership for the NIHR-funded programme of clinical investigations, with responsibility for planning, coordinating and monitoring delivery across multiple interdependent studies involving NHS organisations, academic collaborators, commercial partners and regulatory authorities. Working with delegated authority from the Chief Investigator, the role holder will identify risks, develop mitigation strategies, oversee study governance, manage stakeholder relationships, coordinate resources and budgets, and make operational decisions necessary to achieve programme milestones.

The role holder will represent the programme internally and externally, establish effective working relationships across partner organisations, lead operational meetings and contribute to the continuous improvement of study processes and systems. The post holder will be accountable for maintaining regulatory compliance, participant safety, data integrity and delivery of study objectives within agreed timelines and funding requirements.

Fixed-term: The funds for this post are available until 31 August 2027 in the first instance.

The University actively supports equality, diversity and inclusion and encourages applications from all sections of society.

The University has a responsibility to ensure that all employees are eligible to live and work in the UK.