Senior Clinical Study Manager

Danaher Corporation

3d•$120,000 - $150,000•Remote

About The Position

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. The Senior Clinical Study Manager is responsible for clinical trial execution within the US and EU regions for Leica Biosystems. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. As the Senior 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 is part of the Clinical Development team and will report to the Senior Manager, Clinical Programs and will be a remote role.

Requirements

Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years work experience or Master’s degree with 6+ years of related experience
Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, strategic and tactical planning, written and verbal communication, and project management principles for clinical studies
Experience working with all levels of management and consulting with key internal business stakeholders, with the proven ability to influence
Direct experience with Immunohistochemistry (IHC) operational workflows
Ability to work in a global environment

Nice To Haves

Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Companion Diagnostics (CDx), Computational Pathology, Immunohistochemistry (IHC) and In Situ Hybridization (ISH).
Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs
Professional certification in Clinical Research (e.g., SoCRA, ACRP).

Responsibilities

Provide strategic oversight into the operational planning and execution of complex programs and individual In Vitro Diagnostics (IVD) clinical studies from concept to close-out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
Oversee site and vendor selection and management activities for clinical trial services, ensuring contracts, scope of work, and performance metrics align with study objectives and Standard Operating Procedures (SOPs).
Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct - this includes the development and writing of clinical study protocols, informed consent forms, and other essential study documents, ensuring scientific rigor and operational feasibility.
Establish and maintain robust communication channels with investigators, site staff, internal stakeholders, and external partners to facilitate smooth study progress and timely issue resolution
Conduct regular reviews of clinical study data, site monitoring reports, and operational metrics to identify trends, ensure data integrity, and proactively address any performance or quality issues.
Act as a key point of contact and actively support internal and external audits and regulatory inspections, ensuring timeline provision of documentation and addressing any findings or observations.