At a Glance
- Tasks: Lead global clinical trials, manage stakeholders, and oversee trial operations.
- Company: Join a growing biotech company at the forefront of innovative therapeutic research.
- Benefits: Enjoy a hybrid work model with flexible in-office days and competitive salary.
- Why this job: Be part of groundbreaking clinical research and make a real impact on healthcare.
- Qualifications: Requires a Bachelor's degree and 8+ years in clinical trial management.
- Other info: Opportunity for mentorship and leadership in a dynamic, collaborative environment.
The predicted salary is between 54000 - 84000 £ per year.
A growing, innovative biotech company is seeking a Senior Clinical Trial Manager to lead the planning, execution, and oversight of a First-in-Human (FIH) clinical trial for a novel therapeutic candidate. This role provides the opportunity to work at the forefront of clinical research, managing global end-to-end trial activities and ensuring alignment with clinical and regulatory milestones. The successful candidate will bring a strategic mindset, operational excellence, and strong leadership skills to help advance the company’s clinical development goals in a dynamic and collaborative environment.
Key Responsibilities
- Lead day-to-day operations for global clinical trials across major functional areas, with an initial emphasis on start-up activities.
- Manage site feasibility, site selection, site initiation, and ongoing monitoring processes.
- Serve as the primary point of contact for all clinical trial stakeholders including internal teams, CROs, and other external vendors.
- Oversee financial aspects of the trial including vendor budgets, investigator grants, invoice reviews, and forecasting.
- Organize and lead clinical trial trainings such as investigator meetings and site initiation visits.
- Contribute to the development and finalization of key trial documents including study protocols and clinical study reports.
- Coordinate IRB/IEC and regulatory submissions to support global trial compliance and timelines.
- Champion proactive communication, accountability, and problem-solving across cross-functional teams.
- Conduct risk assessments and mitigation planning throughout trial execution.
- Support regulatory inspections and quality audits as a Subject Matter Expert (SME).
- Provide mentorship and leadership to junior Clinical Operations staff as needed.
Qualifications
- Bachelor’s degree (or equivalent experience), preferably in a life science or health-related discipline.
- Minimum of 8 years of experience in clinical trial management within pharmaceutical, biotech, or CRO settings.
- Proven expertise in global trial conduct, vendor oversight, and stakeholder management.
- Strong knowledge of clinical research methodologies, Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements.
- Effective at managing timelines, budgets, and collaborative vendor relationships.
- Demonstrated leadership in fostering cross-functional collaboration and delivering operational results.
- Willingness to travel up to 20% as needed.
Senior Clinical Trial Manager employer: Biotech Partners
Contact Detail:
Biotech Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Trial Manager
✨Tip Number 1
Network with professionals in the biotech and clinical trial management fields. Attend industry conferences or local meetups in Boston to connect with potential colleagues and learn about the latest trends and opportunities.
✨Tip Number 2
Familiarise yourself with the specific therapeutic areas relevant to the company’s pipeline. Understanding their novel therapeutic candidates can give you an edge in discussions during interviews and show your genuine interest in their work.
✨Tip Number 3
Prepare to discuss your experience with global trial conduct and vendor management in detail. Be ready to provide examples of how you've successfully navigated challenges in previous roles, as this will demonstrate your operational excellence.
✨Tip Number 4
Showcase your leadership skills by discussing any mentorship experiences you’ve had. Highlighting your ability to lead and develop junior staff can set you apart as a candidate who not only manages but also nurtures talent within the team.
We think you need these skills to ace Senior Clinical Trial Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical trial management, particularly in biotech or pharmaceutical settings. Emphasise your leadership skills and any specific achievements related to global trial conduct.
Craft a Compelling Cover Letter: Write a cover letter that showcases your strategic mindset and operational excellence. Mention your familiarity with Good Clinical Practice (GCP) and ICH guidelines, and how these align with the company's goals.
Highlight Key Responsibilities: In your application, clearly outline your experience with site feasibility, vendor oversight, and stakeholder management. Use specific examples to demonstrate your ability to manage timelines and budgets effectively.
Showcase Leadership Experience: Include details about your mentorship roles and how you've fostered collaboration within cross-functional teams. This will illustrate your capability to lead and support junior staff, which is crucial for this position.
How to prepare for a job interview at Biotech Partners
✨Showcase Your Leadership Skills
As a Senior Clinical Trial Manager, you'll need to demonstrate strong leadership abilities. Prepare examples of how you've successfully led teams in previous roles, particularly in managing clinical trials and fostering collaboration across departments.
✨Understand Regulatory Requirements
Familiarise yourself with Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements. Be ready to discuss how you have ensured compliance in past projects and how you would approach regulatory submissions for the new trial.
✨Highlight Your Strategic Mindset
This role requires a strategic approach to trial management. Think about how you've planned and executed clinical trials in the past, and be prepared to share your thought process on aligning trial activities with clinical and regulatory milestones.
✨Prepare for Financial Discussions
Since overseeing financial aspects is crucial, brush up on your experience with budgeting, vendor management, and financial forecasting. Be ready to discuss specific instances where you managed budgets effectively and how you handled any financial challenges.