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- Tasks: Lead UK clinical trial submissions and ensure compliance with regulatory standards.
- Company: Join a high-performing start-up team dedicated to impactful clinical research.
- Benefits: Gain valuable experience, develop skills, and work in a dynamic environment.
- Why this job: Make a real difference in clinical trials while collaborating with industry experts.
- Qualifications: 1-2 years in UK clinical trial start-up and strong organisational skills.
- Other info: Opportunity for growth and learning in a fast-paced, supportive setting.
The predicted salary is between 36000 - 60000 £ per year.
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.
Start Up Specialist in Maidenhead employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Start Up Specialist in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical trial space on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Start Up Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK clinical trial regulations and the CTA pathway. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed high-volume workloads and tight deadlines. We want to see how you keep everything on track and inspection-ready!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Start Up Specialist in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Start Up Specialist role. Highlight your experience with UK clinical trial submissions and any relevant regulatory activities. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. Don’t forget to mention your understanding of the UK CTA pathway!
Showcase Your Attention to Detail: In this role, accuracy is key. Make sure your application is free from typos and errors. We appreciate candidates who can demonstrate their meticulous nature right from the start!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and we’ll be able to track your application more efficiently. Let’s get started on this journey together!
How to prepare for a job interview at Fortrea
✨Know Your Regulatory Stuff
Make sure you brush up on UK clinical trial regulations and the CTA pathway. Being able to discuss your hands-on experience with submitting CTAs and amendments will show that you’re not just familiar with the process, but that you can lead it.
✨Showcase Your Organisation Skills
Prepare examples of how you've managed high-volume workloads and kept track of multiple submissions. Highlighting your attention to detail and ability to juggle deadlines will demonstrate that you can handle the demands of this role.
✨Communicate Like a Pro
Since you'll be collaborating closely with Clinical Operations Managers and regulatory authorities, practice articulating your thoughts clearly. Be ready to discuss how you've effectively communicated with various stakeholders in past roles.
✨Be Solutions-Focused
Think of instances where you identified risks early or solved problems proactively. Sharing these experiences will show that you have the right mindset for this role and can keep studies inspection-ready.