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- Tasks: Lead and manage Phase 3 clinical trials, ensuring compliance and effective project execution.
- 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 meaningful change in healthcare.
- Qualifications: 8+ years in clinical research with proven trial management experience.
- Other info: Dynamic role with opportunities for growth in a supportive 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 Cheltenham 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 Cheltenham
✨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 CRO oversight. Show them you know your stuff!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your experience in metabolic disease or hepatology. Tailor your approach to highlight your relevant skills and experiences that match their needs.
✨Tip Number 4
Use our website to apply directly! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who can contribute to our mission in clinical trials.
We think you need these skills to ace Clinical Trial Manager (Permanent) in Cheltenham
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. We want to see how your background aligns with 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 clinical trials and how your skills can help us build the clinical infrastructure for our pivotal global trial. Keep it engaging and personal – we love a good story!
Showcase Your CRO Management Skills: Since CRO oversight is key for this role, make sure to highlight your experience in governance, KPI tracking, and performance management. We want to know how you've successfully managed these aspects in your previous roles, so don’t hold back!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy – just a few clicks and you’re done!
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 truly understands the landscape.
✨Showcase Your Experience
Prepare to discuss your past experiences in detail, particularly your role in managing Phase 2/3 trials. Highlight specific examples where you led project plans, managed budgets, or coordinated with CROs. This is your chance to demonstrate your proven track record and how it aligns with their needs.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific challenges, like risk identification or vendor coordination. Think through potential scenarios beforehand and prepare your responses. This will help you articulate your problem-solving skills and proactive approach.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions about their current projects or team dynamics. This shows your genuine interest in the role and helps you gauge if the company culture fits you. Plus, it gives you a chance to engage in a meaningful conversation.