Senior Clinical Study Manager

About the role

The Senior Clinical Study Manager is responsible for clinical trial execution within the US and EU regions for Leica Biosystems, an operating company of Danaher Diagnostics. This role will support Leica Biosystems in developing diagnostic solutions that turn anxiety into answers, and aiding the acceleration of next-generation, life-changing therapies.

Responsibilities

• Independently lead end-to-end study planning and operational delivery, ensuring alignment with regulatory requirements, timelines, and quality standards.
• 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.
• 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.
• 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.

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.
• Previous 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).

Qualifications

• 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).

Skills

• Strategic planning and execution of clinical trials.
• Regulatory compliance and data integrity.
• Project management and leadership skills.
• Communication and collaboration with various stakeholders.
• Experience with Immunohistochemistry (IHC) operational workflows.
• Knowledge of Good Clinical Practice (GCP).

Benefits

At Danaher Diagnostics, we offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan to eligible employees. The salary range for this role is $120,000-$150,000, with the possibility of bonus/incentive pay. For candidates based outside of New York City or applying for roles outside of New York City, additional information about conditions of any job offer can be found here.