Leica Biosystems
Life Sciences
SeniorClinicalStudyManager
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Clinical Study Manager at Leica Biosystems. Skills: Clinical trial execution, Study planning, Operational delivery, Regulatory requirements. Provide strategic oversight into operational planning. Oversee site and vendor selection”
What You'll Achieve.
Achieve critical program milestones; Ensure adherence to protocols; Ensure adherence to GCP; Ensure adherence to regulatory requirements; Ensure alignment with timelines; Ensure alignment with quality standards; Ensure contracts align with study objectives; Ensure scope of work aligns with study objectives; Ensure performance metrics align with study objectives; Ensure efficient study conduct; Ensure successful study conduct; Ensure timely issue resolution; Ensure data integrity; Support internal audits; Support external audits; Support regulatory inspections
Industry & Context.
Resolve issues; Address performance or quality issues
What They're Looking For.
Must Have
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 Have
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)
What You'll Do.
Provide strategic oversight into operational planning
Oversee site and vendor selection
Develop and implement study operational plans
Establish and maintain communication channels
Conduct regular reviews of clinical study data
How You'll Work.
Team & Collaboration
Collaborating cross-functionally; Collaborating with external partners; Consulting with key internal business stakeholders; Communication with investigators; Communication with site staff; Communication with internal stakeholders; Communication with external partners
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management principles, Strategic planning, Tactical planning, Risk mitigation strategies, Budgeting, Resource allocation
Full 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_](https://danaher.com/our-businesses) 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
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