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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 environment with opportunities for growth in a cutting-edge field.
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.
Senior Clinical Trial Manager (m/f/d) in Doncaster employer: LumaBio Partners
Contact Detail:
LumaBio Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Trial Manager (m/f/d) 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 be ready to discuss how you've managed trials and handled CROs in the past. Show them you're the expert they need!
✨Tip Number 3
Don’t forget to showcase your project management skills! Be ready to talk about how you've created and managed study project plans, timelines, and budgets. Use specific examples to demonstrate your success in leading Phase 2/3 trials.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Clinical Trial Manager (m/f/d) in Doncaster
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior 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.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our team. Mention your experience with CRO management and how you’ve successfully led projects in compliance with ICH-GCP and other regulations.
Showcase Your Project Management Skills: We want to see your project management prowess! Include examples of how you've created and managed study project plans, timelines, and budgets. Don’t forget to mention any tools you’ve used, like SmartSheet or MS Project.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at LumaBio Partners
✨Know Your Stuff
Make sure you brush up on the specifics of Phase 3 clinical trials and the regulations involved. Familiarise yourself with ICH-GCP, FDA, EMA, and MHRA guidelines, as well as the therapeutic areas mentioned in the job description. This will show that you're not just interested but also knowledgeable about the field.
✨Showcase Your Experience
Prepare to discuss your previous roles in detail, especially your experience as a project lead or trial manager. Be ready to share specific examples of how you've managed budgets, timelines, and CRO relationships. Highlight any successes or challenges you've faced and how you overcame them.
✨Demonstrate Leadership Skills
As a Senior Clinical Trial Manager, you'll need to lead teams effectively. Think of examples where you've successfully led a team or project, focusing on your communication and problem-solving skills. This is your chance to show how you can inspire and manage others while driving projects forward.
✨Prepare Questions
Interviews are a two-way street, so come prepared with insightful questions about the company's current Phase 3 programme and their expectations for the role. This not only shows your interest but also helps you gauge if the company is the right fit for you.