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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 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
Senior Clinical Trial Manager 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 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 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 the best chance at landing that Senior Clinical Trial Manager role. We want to see your application directly, and it helps us keep track of all the amazing talent out there!
We think you need these skills to ace Senior Clinical Trial Manager 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 area expertise you have. We want to see how your background aligns with our needs!
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.
Showcase Your Leadership Skills: Since this role involves mentoring junior staff, make sure to highlight any leadership or mentoring experience you have. We love seeing candidates who can inspire and develop others while driving projects forward.
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 you’re keen on 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 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 leadership style and how you handle challenges.
✨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 or improved processes, and be ready to discuss the outcomes and what you learned.
✨Engage with the Interviewers
Don’t just wait for questions; engage with your interviewers by asking insightful questions about their current trials and operational challenges. This shows that you're proactive and genuinely interested in contributing to their success.