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- Tasks: Lead global clinical studies in diagnostics, ensuring compliance and strategic alignment.
- Company: Leica Biosystems, a leader in cancer diagnostics with a culture of innovation.
- Benefits: Comprehensive benefits, career growth opportunities, and a collaborative work environment.
- Why this job: Make a real difference in life sciences and improve patient outcomes.
- Qualifications: 10+ years in clinical research with strong leadership and communication skills.
- Other info: Join a diverse team dedicated to advancing cancer diagnostics.
The predicted salary is between 36000 - 60000 £ per year.
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher’s operating companies, our work saves lives—and we’re united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Leica Biosystems is shaping the future of cancer diagnostics, transforming lives with the mission: Advancing Cancer Diagnostics, Improving Lives. As a global leader with a comprehensive portfolio from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can provide patients timely, accurate answers when they need them most. You’ll be part of a diverse, collaborative global community and be inspired to stretch, grow, and make an impact.
The Principal Clinical Study Manager is a senior individual contributor role that provides leadership and strategic oversight for the global execution of complex Companion Diagnostics (CDx) clinical studies. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. As the Principal Clinical Study Manager, you will independently lead end-to-end study planning and operational delivery, ensuring alignment with regulatory requirements, timelines, and quality standards. You will serve as the central point of accountability for study execution, collaborating cross-functionally and with external partners to drive progress, resolve issues, and achieve critical program milestones.
This position reports to the Director, Clinical Development and is part of the Global Clinical Affairs Team located in Newcastle, UK and will be an on-site role.
In this role, you will have the opportunity to:
- Lead global IVD clinical development programs from concept to commercialization, ensuring strategic alignment with corporate goals, regulatory requirements, and portfolio priorities.
- Oversee cross-functional site and vendor strategy, including selection, contract negotiation, performance management, and issue resolution to support enterprise-wide clinical trial execution.
- Develop and implement operational frameworks integrating timelines, budgets, resource planning, and risk management to drive efficient and compliant program delivery.
- Establish governance and communication structures to align internal and external stakeholders, promote transparency, and foster a collaborative, accountable culture.
- Drive performance analytics and quality assurance, leveraging data insights to optimize trial execution, support regulatory submissions, and ensure audit readiness.
The essential requirements of the job include:
- Bachelor’s degree in Life Sciences, Healthcare, or a related field with 10+ years’ experience in clinical research, specifically with significant experience in US and/or EU trials, or a Master’s or Doctoral degree with 8+ years of same experience.
- In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets.
- Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.
- Ability to critically review and interpret scientific and clinical trial data, and oversee the scientific aspects of study protocols and reports.
- Excellent leadership, communication (written and verbal) and interpersonal skills for managing a team and collaborating with cross-functional stakeholders.
It would be a plus if you also possess previous experience in:
- Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Digital Pathology and Immunohistochemistry (IHC) & In Situ Hybridization (ISH).
- Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
- Professional certification in Clinical Research (e.g., SoCRA, ACRP).
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. For more information, visit www.danaher.com.
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Principal Clinical Study Manager employer: Leica Biosystems
Contact Detail:
Leica Biosystems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Clinical Study Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences and diagnostics fields. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand Leica Biosystems' mission and values, and think about how your experience aligns with their goals. This will help you stand out as a candidate who truly gets what they’re all about.
✨Tip Number 3
Practice your pitch! Be ready to explain your experience in clinical research and how it relates to the role of Principal Clinical Study Manager. Highlight your leadership skills and ability to solve complex issues—these are key for this position.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us. Let’s make an impact together!
We think you need these skills to ace Principal Clinical Study Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Principal Clinical Study Manager role. Highlight your leadership in clinical studies and any relevant experience in diagnostics or biotechnology.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you’re passionate about advancing cancer diagnostics. Share specific examples of how you've made an impact in previous roles, especially in clinical research or study management.
Showcase Your Communication Skills: Since this role requires excellent communication, ensure your application is clear and concise. Use professional language but let your personality shine through—show us who you are!
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’s super easy!
How to prepare for a job interview at Leica Biosystems
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical study execution, especially in diagnostics and medical devices. Familiarise yourself with the specific requirements for US and EU trials, as well as any relevant regulations. This will show that you're not just interested in the role but also understand the industry.
✨Showcase Your Leadership Skills
As a Principal Clinical Study Manager, you'll need to demonstrate strong leadership abilities. Prepare examples from your past experiences where you've successfully led teams or projects. Highlight how you resolved conflicts, drove progress, and achieved milestones, as this will resonate well with the interviewers.
✨Be Ready for Problem-Solving Questions
Expect questions that assess your ability to tackle complex issues in clinical trials. Think of specific challenges you've faced and how you approached them. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
✨Understand Their Culture
Leica Biosystems values collaboration and innovation. Research their company culture and be prepared to discuss how your unique viewpoint can contribute to their mission of advancing cancer diagnostics. Showing that you align with their values will make a positive impression.
