Principal Clinical Study Manager

Danaher; Newcastle upon Tyne; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading global diagnostics firm is seeking a Principal Clinical Study Manager to provide leadership in the execution of Companion Diagnostics clinical studies. This role requires extensive experience in clinical research, focusing on compliance with regulatory requirements and strategic alignment with corporate goals. The position is based in Newcastle, UK, and involves cross-functional collaboration to ensure timely and quality deliverables.

Benefits

Comprehensive health care programs

Paid time off

Competitive benefit programs

Qualifications

• 10+ years of experience in clinical research.
• In-depth understanding of clinical study execution in diagnostics or pharmaceutical industry.
• Ability to critically review and interpret scientific data.

Responsibilities

• Lead global IVD clinical development programs.
• Oversee site and vendor strategy.
• Develop operational frameworks for program delivery.
• Establish governance and communication structures.
• Drive performance analytics and quality assurance.

Skills

Leadership

Communication

Problem-Solving

Education

Bachelor's degree in Life Sciences, Healthcare, or related field

Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs

Job description

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 15+ operating companies, our work saves lives-and we're all 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. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most.

When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System which makes everything possible.

Job Description

The Principal Clinical Study Manager is a senior individual contributor role 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.

Responsibilities

• 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.

Requirements

• 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 Masters 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

Preferred Qualifications

• 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. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

We are an equal opportunities employer and welcome applications from all qualified candidates. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.