At a Glance
- Tasks: Lead global clinical trials and ensure high-quality, patient-focused studies.
- Company: Dynamic biotech firm focused on innovative therapies.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Fast-paced environment with a focus on rare diseases and cutting-edge therapies.
- Why this job: Make a real impact in clinical operations and drive advancements in healthcare.
- Qualifications: Extensive experience in clinical operations and strong leadership skills required.
The predicted salary is between 100000 - 150000 € per year.
The Vice President of Clinical Operations and Data Management (CODM) provides strategic leadership for the planning, execution, and oversight of global clinical trials. This role is accountable for delivering high-quality, compliant, patient‑focused studies on time and within budget, while advancing the organization’s clinical development strategy and supporting global regulatory and commercialization objectives.
Key Elements And Responsibilities
- Provide strategic and operational leadership for clinical operations and data management across programs, from study start‑up through close‑out, in compliance with ICH‑GCP.
- Ensure the quality, integrity, and inspection‑readiness of all clinical and data management activities globally.
- Drive cross‑functional collaboration to deliver clinical trials on time and within budget.
- Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
- Act as the primary escalation point for critical study and vendor issues.
- Oversee study budgets, timelines, resources, and financial tracking.
- Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of clinical documentation and data management activities.
- Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
- Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
- Ensure robust data integrity, accurate record‑keeping, and compliant archiving practices.
- Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
- Build and maintain strong relationships with investigators and key opinion leaders.
- Lead, develop, and mentor high‑performing teams.
- Ensure delivery of high‑quality study documentation to meet program timelines.
Requirements, Skills & Knowledge
- Extensive experience in clinical operations leadership within biotech/pharma.
- Strong clinical project and program management expertise.
- Proven track record managing CROs and external vendors.
- Solid understanding of global regulatory requirements (ICH‑GCP).
- Experience managing budgets and resource planning.
- Strong problem‑solving skills with the ability to operate strategically and tactically.
- Excellent leadership, communication, and stakeholder management skills.
- Ability to thrive in a fast‑paced, evolving biotech environment.
- Experience in rare/orphan diseases and/or academic collaborations is a plus.
Education
- Bachelor's degree in Life Sciences required.
- Advanced degree (MS, PhD, or equivalent) preferred.
- Substantial experience leading Clinical Operations and Data Management teams.
- Experience in rare disease; gene and cell therapy experience is a plus.
VP, Clinical Operations and Data Management in London employer: Orchard Therapeutics - U.S.
As a leading organisation in the biotech sector, we pride ourselves on fostering a dynamic and inclusive work culture that prioritises employee growth and development. Located in the vibrant city of London, our team enjoys access to cutting-edge resources and collaborative opportunities, ensuring that every member can contribute meaningfully to innovative clinical trials while advancing their career in a supportive environment.
Contact Detail:
Orchard Therapeutics - U.S. Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land VP, Clinical Operations and Data Management in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical operations and data management field. Attend industry events, webinars, or even local meet-ups to make those valuable contacts that could lead to your next big opportunity.
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Show them you’re not just another candidate; demonstrate your passion for their mission and how your experience aligns with their goals in clinical trials and data management.
✨Tip Number 3
Practice your pitch! Be ready to articulate your leadership style and how you've successfully managed clinical operations in the past. Use specific examples that highlight your problem-solving skills and ability to drive projects forward.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it shows you’re genuinely interested in being part of our team!
We think you need these skills to ace VP, Clinical Operations and Data Management in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the VP, Clinical Operations and Data Management role. Highlight your leadership in clinical operations and any relevant experience with CROs or regulatory requirements.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you're passionate about clinical trials and how your background makes you the perfect fit for our team. Be sure to mention any experience with rare diseases or academic collaborations.
Showcase Your Achievements:When detailing your past roles, focus on quantifiable achievements. Did you lead a project that came in under budget? Or perhaps you improved study timelines? We love numbers and results, so make them stand out!
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!
How to prepare for a job interview at Orchard Therapeutics - U.S.
✨Know Your Clinical Operations Inside Out
Make sure you brush up on your knowledge of clinical operations and data management. Understand the key elements of ICH-GCP and be ready to discuss how you've applied these principles in your previous roles. This will show that you're not just familiar with the theory, but that you can also implement it effectively.
✨Showcase Your Leadership Skills
As a VP, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've led teams through challenging projects or managed cross-functional collaborations. Highlight your experience in mentoring and developing high-performing teams, as this is crucial for the role.
✨Be Ready to Discuss Budget Management
Since overseeing study budgets is a key responsibility, come prepared with specific examples of how you've managed budgets in past projects. Discuss any challenges you faced and how you overcame them, as well as your approach to financial tracking and resource planning.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and ability to handle critical study issues. Think about past experiences where you had to make tough decisions or navigate complex situations, and be ready to articulate your thought process and outcomes.