Join a dedicated, high‑performing start‑up team supporting a single key client in the delivery of UK clinical trial submissions. In this role, you will take ownership of country‑level regulatory activities, from initial CTA preparation through ongoing maintenance, amendments, and safety‑related submissions. Working closely with the client’s Clinical Operations Managers, you’ll play a critical part in meeting their stringent KPIs, ensuring accuracy, compliance, and timely delivery of all regulatory milestones.
What You’ll Do
- Lead UK country‑level submission activities for initial Clinical Trial Applications (CTAs), ensuring high‑quality, complete, and compliant packages.
- Manage ongoing maintenance submissions, including substantial and non‑substantial amendments, ensuring all updates are submitted within required timelines.
- Support relevant safety‑reporting activities in line with regulatory expectations and client requirements.
- Collaborate closely with the client’s Clinical Operations Managers to help achieve key performance indicators and operational targets.
- Maintain meticulous tracking of all submission activities, timelines, and status updates across multiple systems and trackers.
- Package, file, and archive submission documents and all related correspondence according to the client’s standards and SOPs.
- Partner with cross‑functional teams and UK authorities (e.g., MHRA, REC) to support efficient and timely processing of applications.
- Provide expert review of regulatory documentation, ensuring consistency, accuracy, and high‑quality submissions.
What You Bring
- 1–2+ years’ experience in UK clinical trial start‑up, with hands‑on experience submitting UK ‘country‑level’ CTIMPs to all applicable UK regulatory bodies and a solid understanding of the UK CTA pathway.
- Practical experience preparing Clinical Trial Applications, Amendments, and Safety Reporting, with an advantage for candidates competent in completing the Medicines
Information Form (MIF)—accurately detailing Investigational Medicinal Products (IMPs) alongside the required ethics information.
- Solid knowledge of ICH‑GCP, UK clinical trial regulations, and EC/IRB/MHRA submission processes.
- Proven ability to manage a high‑volume workload, juggle competing deadlines, and maintain detailed tracking with accuracy.
- Strong organisation, attention to detail, and confidence in managing communication with client representatives, investigator site teams, and regulatory authorities.
- A proactive, solutions‑focused approach with the ability to identify risks early and keep studies inspection‑ready.
Learn more about our EEO & Accommodations request here.
