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 clinical operations.
- Other info: Dynamic role with opportunities for professional growth and development.
- 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.
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.
Senior Clinical Trial Manager in Wakefield employer: LumaBio Partners
Join a pioneering biopharmaceutical company at the forefront of developing innovative treatments for serious metabolic liver disease. As a Senior Clinical Trial Manager, you will be part of a dynamic and high-calibre team, enjoying a culture that values ownership, collaboration, and professional growth. With direct access to senior leadership and opportunities to mentor junior staff, this role offers a unique chance to shape clinical operations while working on impactful global trials across the US and Europe.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Trial Manager in Wakefield
✨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 a referral.
✨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. Check out our website for opportunities that match your skills in clinical trial management, especially in metabolic diseases.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Share a relevant insight from your conversation to show your enthusiasm and reinforce your fit for the role.
We think you need these skills to ace Senior Clinical Trial Manager in Wakefield
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 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 this role 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 position.
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 seeing candidates who can inspire and guide 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 us you're keen on joining our team at this exciting time!
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. Being able to discuss recent studies or advancements will show your genuine interest and expertise in the field.
✨Showcase Your Leadership Skills
As a Senior Clinical Trial Manager, you'll need to demonstrate your ability to lead teams and manage CROs effectively. Prepare examples from your past experiences where you've successfully led projects, mentored staff, or improved processes.
✨Understand Regulatory Requirements
Familiarise yourself with ICH-GCP, FDA, EMA, and MHRA regulations. Be ready to discuss how you've ensured compliance in previous roles and how you would approach risk management and regulatory challenges in this position.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current Phase 3 study and their vision for the future. This not only shows your enthusiasm but also helps you gauge if the company aligns with your career goals and values.
