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- Tasks: Lead and manage Phase 3 clinical trials, ensuring compliance and operational excellence.
- Company: Join a pioneering biopharmaceutical company focused on innovative liver disease treatments.
- Benefits: Competitive salary, mentorship opportunities, and the chance to shape clinical operations.
- Why this job: Make a real impact in advancing groundbreaking therapies while leading a high-calibre team.
- Qualifications: 8+ years in clinical research with strong project management skills and CRO experience.
- Other info: Dynamic environment with opportunities for professional growth and development.
The predicted salary is between 60000 - 80000 £ per year.
We are supporting a late clinical stage biopharmaceutical company advancing a first-in-class treatment of serious metabolic liver disease. 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. You will have real ownership, direct senior access, and the chance to shape how they operate.
THE ROLE
As Senior/Clinical Trial Manager, you will own end-to-end execution of one or more Phase 3 studies. You will be the primary operational lead on the sponsor side, managing CROs, vendors, investigative sites, and cross-functional teams across the US and Europe. The role reports directly to Senior Leadership. For the Senior CTM level, you will additionally take accountability for functional leadership, mentoring junior clinical operations staff, and contributing to process and system development as we scale.
WHAT YOU'LL DO
- 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.
- Lead or participate in investigative site meetings, KOL interactions, and vendor selection activities.
- Mentor and develop junior clinical operations personnel (Senior CTM level).
- Participate in process improvement and operational scaling initiatives as the organisation grows.
WHAT WE'RE LOOKING FOR
- 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.
- Direct experience managing global trials with US and European sites practical knowledge of EMA, MHRA, and national competent authority processes.
- 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.
Locations
Senior Clinical Trial Manager in Basingstoke, Hampshire employer: LumaBio Partners
Contact Detail:
LumaBio Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Trial Manager in Basingstoke, Hampshire
✨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 showcase your expertise in managing global trials and CROs, so practice articulating your experiences clearly.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each company’s mission and culture.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
We think you need these skills to ace Senior Clinical Trial Manager in Basingstoke, Hampshire
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 area expertise you have, especially in metabolic diseases. 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 this opportunity and how your skills can contribute to our mission. Be sure to mention your experience with CRO management and global trials, as these are key aspects of the role.
Showcase Your Leadership Skills: As a Senior CTM, you'll be mentoring junior staff and leading projects. Make sure to highlight any leadership experiences you've had in your application. We love to see examples of how you've driven teams towards success and improved processes in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us that you’re genuinely interested in joining our team!
How to prepare for a job interview at LumaBio Partners
✨Know Your Stuff
Make sure you brush up on the latest developments in metabolic liver disease and the specifics of Phase 3 trials. Familiarise yourself with ICH-GCP guidelines and the regulatory requirements for both the US and Europe. This will show that you're not just interested in the role, but that you’re genuinely invested in the field.
✨Showcase Your Leadership Skills
As a Senior Clinical Trial Manager, you'll need to demonstrate your ability to lead teams and mentor junior staff. Prepare examples from your past experiences where you've successfully managed cross-functional teams or improved processes. Highlighting these skills will help you stand out as a candidate who can take ownership and drive results.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving abilities, especially around risk management and CRO oversight. Think of specific scenarios where you identified risks in a trial and how you mitigated them. This will showcase your proactive approach and operational expertise.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current Phase 3 studies and their vision for the future. Inquire about their approach to vendor management and how they ensure compliance across jurisdictions. This not only shows your interest but also helps you gauge if the company aligns with your career goals.