Start Up Specialist
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Job Location:
Maidenhead - UK
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Join a dedicated highperforming startup team supporting a single key client in the delivery of UK clinical trial this role you will take ownership of countrylevel regulatory activities from initial CTA preparation through ongoing maintenance amendments and safetyrelated submissions. Working closely with the clients Clinical Operations Managers youll play a critical part in meeting their stringent KPIs ensuring accuracy compliance and timely delivery of all regulatory milestones.
What Youll Do
- Lead UK countrylevel submission activities for initial Clinical Trial Applications (CTAs) ensuring highquality complete and compliant packages.
- Manage ongoing maintenance submissions including substantial and nonsubstantial amendments ensuring all updates are submitted within required timelines.
- Support relevant safetyreporting activities in line with regulatory expectations and client requirements.
- Collaborate closely with the clients 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 clients standards and SOPs.
- Partner with crossfunctional 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 highquality submissions.
What You Bring
- 12 years experience in UK clinical trial startup with handson experience submitting UK countrylevel 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 ICHGCP UK clinical trial regulations and EC/IRB/MHRA submission processes.
- Proven ability to manage a highvolume 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 solutionsfocused approach with the ability to identify risks early and keep studies inspectionready.
Learn more about our EEO & Accommodations request here.
Required Experience:
IC
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