Overview
Principal Clinical Study Manager is a senior individual contributor role providing leadership and strategic oversight for global execution of complex Companion Diagnostics (CDx) clinical studies. This role supports Leica Biosystems, an operating company of Danaher Diagnostics. 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.
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.
Essential Requirements Of The Job Include
* Bachelor’s degree in Life Sciences, Healthcare, or a related field with 10+ years’ experience in clinical research, or a Masters/Doctoral with 8+ years of similar experience.
* In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with products intended for 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.
The following are a plus
* Experience in study designs for in vitro diagnostic technologies (IVD), specifically 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. 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.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
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