Manager, Clinical Site Operations

Leica Biosystems – Manager, Clinical Site Operations – New York, NY

Location: New York, NY Employment Type: Full Time

Job Description

Manager, Clinical Site Operations

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 are united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where your unique viewpoint matters. 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 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.

Role Overview

The Manager, Clinical Site Operations is responsible for leading and developing a team of Clinical Research Associates and overseeing all clinical trial site operations for Danaher Diagnostics. You will ensure regional clinical activities are conducted efficiently, compliantly, and to the highest quality standards, contributing to the success of our clinical studies. This position reports to the Senior Director, Clinical Site Operations and is part of the Clinical Site Operations Team working remote.

In this role, you will have the opportunity to:

• Lead and develop a team of Clinical Research Associates (CRAs), supporting their professional development and ensuring high performance.
• Oversee and manage clinical trial site activities within the region, including site selection, initiation, monitoring, close-out, and issue resolution, ensuring adherence to study protocols and timelines.
• Ensure all regional site operations activities comply with Good Clinical Practice (GCP), US FDA regulations, applicable local requirements, and company Standard Operating Procedures (SOPs).
• Monitor regional site performance against key metrics (e.g., enrollment, data quality, monitoring visit frequency) and implement corrective actions as needed.
• Serve as the primary point of contact and escalation for CRAs and clinical sites within the region, troubleshooting operational issues.
• Collaborate closely with the Senior Director, Clinical Site Operations, other regional managers, and cross-functional teams (e.g., Project Management, Regulatory Affairs) to align regional activities with overall clinical strategy and goals.
• Contribute to the development and implementation of regional strategies, processes, and training for clinical site operations.

Essential requirements

• Bachelors Degree in field with 6+ years of experience or a Masters Degree with 4+ years of experience or PhD with 2+ years of experience.
• Two plus (2+) years leading teams and managing people.
• Knowledge and experience with Good Clinical Practice (GCP) and global IVD medical device or pharmaceutical regulations.

Preferred qualifications

• Previous experience in diagnostics, medical device, or pharmaceutical industry.
• Experience managing clinical operations or monitoring across multiple states within a US region.
• Experience contributing to the development or implementation of standard operating procedures or training materials.
• Familiarity with electronic clinical trial systems (CTMS, EDC, eTMF).
• Professional certification in Clinical Research (e.g., SoCRA, ACRP).

Travel Requirements: 10% travel

Compensation and…