Study Manager

The University of Sheffield is a remarkable place to work. Our people are at the heart of everything we do. Their diverse backgrounds, abilities and beliefs make Sheffield a world-class university.

We offer a fantastic range of benefits including a highly competitive annual leave entitlement (with the ability to purchase more), a generous pensions scheme, flexible working opportunities, a commitment to your development and wellbeing, a wide range of retail discounts, and much more. 

You will work closely with Sheffield Clinical Trials Research Unit (CTRU) staff and with the study Chief Investigator(s) to conduct research, coordinate and deliver one or more multi-site research studies.  You will work closely with other members of the study team (e.g. the Chief Investigator, statisticians and data managers) to ensure the implementation of all aspects of studies, including obtaining regulatory approvals, recruiting sites, supporting participant recruitment and final report writing.  You may also supervise staff at study sites and undertake quality control responsibilities related to studies including site monitoring.

Previous experience in the management and coordination of large multicentre trials is essential

Main duties and responsibilities

Working under the supervision of a Senior Research Fellow, you will be responsible for coordinating all aspects of studies, including:

• Establishing study procedures and processes and ensuring participating centres have the appropriate documentation, information and training to comply with these. This includes protocol development, obtaining ethics and regulatory approval and the establishment of governance arrangements (e.g. Advisory, Project Management Committees).
• Implementation of research studies in accordance with protocols and across multiple sites.  This includes recruiting and liaising with NHS and social care sites; training and supervising trial staff at sites to ensure the effective running of the study protocol.
• Ensuring the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management.
• Data collection and reporting, including supervision and co-ordination of other researchers where appropriate.
• Ensuring compliance with research ethics, clinical governance and data protection and good clinical practice requirements.
• Liaison with clinicians, research collaborators, and with members of the study team to ensure completion of the health economic evaluation.
• Liaison with statisticians to ensure statistical analysis is undertaken.
• Provision of regular and ad hoc information, both written and verbal, to the trial participants, collaborators and funders, to include reports, updates, guidance, newsletters and website, ensuring that these meet legislative, contractual and ethical requirements.
• Reading relevant academic papers to update knowledge of current research areas.
• Coordination of the trial team’s input to the final report and all trial publications for academic journals, as well as providing input to the preparation of papers.
• Travel to sites around the UK to undertake study site monitoring.
• Acting as the point of contact for all external and internal agencies.
• Oversight of the creation and maintenance of all trial files, Including the trial master file, and overview of site files.
• May be responsible for the supervision of study-specific staff.

Any other duties, commensurate with the grade of the post.

Planning and Organising

• The overall efficient day-to-day management of the trial.
• Plan work to assist delivery of studies within agreed timescales.
• Prioritise tasks to ensure allocation of time to different studies as appropriate to demands.
• Oversee work of study staff where relevant.
• Ensure reliability of the data by collaboration with the CTRU data management team.
• Advance planning to meet deadlines for formal project monitoring and study milestones (e.g. participant recruitment, data collection and data analysis).
• Advance planning to meet deadlines for dissemination e.g. reports and papers.
• Develop agendas and materials for research project meetings.
• Managing and monitoring the study budgets.