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For Companies At a Glance
- 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 impactful clinical research.
- Why this job: Be part of a high-calibre team at a pivotal moment in medical innovation.
- Qualifications: 8+ years in clinical research with strong project management skills.
- Other info: Opportunity for career growth and leadership in a dynamic environment.
The predicted salary is between 60000 - 80000 £ per year.
Company Overview
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 Basildon, Essex 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 Basildon, Essex
✨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 diving deep into the company’s recent projects and their approach to clinical trials. Show them you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website for a smoother process! We love seeing candidates who take the initiative to connect directly with us. Plus, it gives you a better chance to stand out from the crowd.
We think you need these skills to ace Senior Clinical Trial Manager in Basildon, Essex
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.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your project management skills and how you've successfully led global trials in the past.
Showcase Your Leadership Skills: Since this role involves mentoring junior staff, don’t forget to mention your leadership experience. We want to see how you've developed others in your previous roles and contributed to team success.
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 this exciting opportunity right away!
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 Phase 3 trial processes. Familiarise yourself with ICH-GCP guidelines and the specific regulations of the EMA and MHRA. This will not only show your expertise but also your genuine interest in the role.
✨Showcase Your Leadership Skills
As a Senior Clinical Trial Manager, you'll be expected to lead teams and mentor junior staff. Prepare examples from your past experiences where you've successfully managed teams or projects, highlighting your ability to drive results and foster collaboration.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills, especially around risk management and CRO oversight. Think of specific scenarios where you identified risks and how you mitigated them, as well as how you handled vendor relationships and performance management.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current Phase 3 studies and their approach to clinical trial management. This shows your enthusiasm for the role and helps you gauge if the company culture aligns with your values and work style.