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- Tasks: Lead Phase 3 clinical trials and manage project plans, budgets, and vendor coordination.
- Company: Join a high-calibre team at a pivotal moment in clinical research.
- Benefits: Competitive salary, professional development, and the chance to make a real impact.
- Why this job: Be at the forefront of innovative therapies and drive global clinical trials.
- Qualifications: 8+ years in clinical research with proven trial management experience.
- Other info: Dynamic role with opportunities for growth in a collaborative environment.
The predicted salary is between 60000 - 80000 £ per year.
Their lead programme is entering Phase 3, a significant inflection point for both the asset and the organisation. This is a rare opportunity to join a focused, high-calibre team at the moment it matters most: building the clinical infrastructure to take a differentiated therapy through a pivotal global trial.
As Senior/Clinical Trial Manager, you will own end-to-end execution of one or more Phase 3 studies:
- Lead the creation and management of study project plans, timelines, budgets, resourcing, and vendor coordination from concept through final CSR.
- Serve as the primary sponsor-side operational lead for CRO oversight, including governance cadence, KPI tracking, and performance management.
- Ensure all trials are conducted in compliance with ICH-GCP, FDA, EMA, MHRA, and applicable local regulations across multiple jurisdictions.
- Drive proactive risk identification and mitigation, owning the risk register and escalating appropriately to the medical monitor and VP.
- Manage IP logistics, clinical lab samples, and ancillary supply shipments across US and European sites.
- Review SAEs and pertinent safety data with the medical monitor and drug safety team to identify trends and signals.
- Ensure ongoing compilation, organisation, and reconciliation of the Trial Master File.
Requirements:
- 8+ years of clinical research experience in an industry (sponsor-side) setting.
- Minimum 3 years as a project lead or trial manager, with clear ownership of Phase 2/3 trial execution.
- Proven CRO management track record: governance, SLAs, performance escalation.
- Strong working knowledge of GCP, ICH guidelines, and multi-jurisdictional regulatory requirements.
- Experience with TMF management, budget tracking, and trial tools (SmartSheet, MS Project, Veeva, Medidata or similar).
- Therapeutic area experience in metabolic disease, hepatology, GI, or cardiometabolic strongly preferred.
Clinical Trial Manager (Permanent) in Doncaster employer: LumaBio Partners
Contact Detail:
LumaBio Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager (Permanent) in Doncaster
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who have experience with Phase 3 trials. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ICH-GCP and regulatory requirements. We want you to shine when discussing your experience managing CROs and trial execution. Practice common interview questions to boost your confidence!
✨Tip Number 3
Showcase your project management skills! Be ready to discuss specific examples of how you've created and managed study project plans, timelines, and budgets. Highlight your ability to drive proactive risk identification and mitigation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our focused, high-calibre team.
We think you need these skills to ace Clinical Trial Manager (Permanent) in Doncaster
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Trial Manager role. Highlight your relevant experience in managing Phase 2/3 trials and any specific therapeutic areas you've worked in, like metabolic disease or hepatology.
Showcase Your Skills: In your cover letter, showcase your skills in project management, CRO oversight, and compliance with regulations. We want to see how you’ve driven risk identification and managed budgets in previous roles.
Be Clear and Concise: Keep your application clear and concise. Use bullet points where possible to make it easy for us to see your achievements and responsibilities at a glance. We love a well-structured application!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity to join our high-calibre team.
How to prepare for a job interview at LumaBio Partners
✨Know Your Stuff
Make sure you brush up on the specifics of clinical trial management, especially Phase 3 studies. Familiarise yourself with ICH-GCP guidelines and the regulatory requirements for the jurisdictions involved. This will show that you're not just a candidate, but someone who understands the intricacies of the role.
✨Showcase Your Experience
Prepare to discuss your previous experiences in detail, particularly your roles as a project lead or trial manager. Highlight specific examples where you successfully managed budgets, timelines, and vendor coordination. This is your chance to demonstrate your proven track record in CRO management and trial execution.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills, especially around risk identification and mitigation. Think of scenarios from your past work where you had to manage unexpected challenges and how you handled them. This will help illustrate your proactive approach and leadership capabilities.
✨Familiarise Yourself with the Company’s Pipeline
Research the company’s lead programme and its significance in the market. Understanding their therapeutic focus, especially in metabolic disease or hepatology, will allow you to align your answers with their goals and demonstrate your genuine interest in contributing to their success.