Job overview
Ensure high-quality maintenance of study documentation across the trial
lifecycle, including amendments, annual reports, monitoring follow-up,
close-out, and archiving.
Keeps 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, time of study closure.
Support and lead a team that is administrates monthly HTU Trial Steering
Committee (TSC) Meeting preparing agenda items, ensuring meetings
are quorate, taking minutes, 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 oversi...