Ensure high-quality maintenance of study documentation across the trial lifecycle, including amendments, annual reports, monitoring follow-up, close-out, and archiving. Keep an accurate database of HTU trials, timelines of trial approval by HTU TSC, time to securing slots from OUH R+D, time to first patient first visit, total recruitment, and time of study closure. Support and lead a team that administers monthly HTU Trial Steering Committee (TSC) meetings, preparing agenda items, ensuring meetings are quorate, taking minutes, and ensuring actions are completed. Support oversight and continued improvement of QMS processes, including controlled documents, protocol, amendments, training records, and CAPA tracking. Ensure accurate data reporting and document tracking through established systems, including trial databases and central trackers. Maintain inventories, dashboards, and oversight tools to support operational performance reporting. Handle confidential and sensitive information appropriately, adhering to information governance standards.
The Senior Trial Administrator will provide advanced administrative oversight and coordination across a portfolio of Haematology clinical trials within the Haematology Trials Unit (HTU). Building on the Band 5 Trial Administrator role, the Senior Trial Administrator will lead setup-related activities of Haematology Clinical Trials, ensuring compliance with UK GCP, regulatory requirements, OUH policies, and sponsor expectations. The post holder will act as a senior point of contact for consultants, research nurses, data teams, and external partners, supporting the efficient management of trials from setup to closeout. This role will also oversee trial documentation, contribute to managing several studies of varying complexity across the full lifecycle, including setup, amendment, maintenance, closeout, and support reporting obligations to sponsors and regulatory bodies. In addition, the Senior Trial Administrator will line‑manage a Trial Administrator, contributing to staff development, allocating workloads, ensuring quality of administrative work, and supporting continuous improvement.
Qualifications
- Significant experience administering clinical trials, including setup, document management, amendments, and site file oversight.
- Strong working knowledge of GCP, UK clinical research governance, ethics and regulatory processes (e.g., IRAS, MHRA notifications).
- Experience supporting or coordinating complex studies or multi‑centre research.
- Experience working with QMS processes (e.g., SOP updates, CAPA tracking, audit preparation).
Desirable
- Experience in Haematology or oncology research settings.
- Experience liaising with external partners such as industry sponsors or CROs.
- Graduate degree in Biological Sciences or a related scientific discipline, with substantial experience in clinical research administration.
- Good Clinical Practice training and evidence of further relevant professional development.
- Further/higher education in a relevant discipline (e.g., life sciences, health research).
- Formal training in research governance or project administration.
- Excellent written and verbal communication skills, including producing high quality reports and formal correspondence.
- Strong organisational skills with ability to prioritise complex workloads and meet deadlines.
- High degree of accuracy and attention to detail across all administrative responsibilities.
- Proficient IT skills in MS Office, document control tools, and trial management systems.
- Ability to work autonomously and collaboratively within multidisciplinary teams.
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