Remote Senior Manager, Clinical Programs & Trials

Leica Biosystems Inc.; Vista (CA); Remote; USD 145,000 - 175,000; Full time

Benefits offered by this job

Remote work arrangement

Bonus eligible

Job summary

Leica Biosystems, a Danaher operating company, seeks a Senior Manager, Clinical Programs to lead global clinical study execution across Digital Pathology, IHC/ISH, CDx, and Medical Device programs. You will manage a team of clinical study managers, ensuring regulatory compliance and timely milestones in US and EU markets.

Reporting to the Director, Clinical Development within Global Clinical Affairs, you will collaborate with Clinical Science, Regulatory Affairs, Data Management, Biostatistics,

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 7+ years in clinical research (US/EU trials).
• Master’s or Doctoral degree with 5+ years’ experience in clinical research.
• Experience leading clinical study managers and cross‑functional teams.
• Strong knowledge of ICH-GCP, regulatory requirements, SOPs and study protocols.
• Ability to review scientific data and oversee study protocols and reports.
• Excellent leadership and interpersonal communication skills.

Responsibilities

• Provide strategic oversight for multiple clinical studies in Digital Pathology, IHC/ISH, CDx, and Medical Device.
• Lead, mentor, and manage a team of clinical study managers.
• Ensure studies comply with ICH-GCP and regulatory requirements.
• Manage program timelines, budgets, and resources; mitigate risks.
• Collaborate with cross‑functional teams to ensure data integrity and trial conduct.
• Oversee site selection and management for clinical activities and quality standards.

Skills

Leadership experience

Regulatory knowledge

Clinical study execution

Data interpretation

Communication skills

Education

Bachelor's degree + 7+ years

Master's/Doctoral + 5+ years

Job description

Leica Biosystems, a Danaher operating company, seeks a Senior Manager, Clinical Programs to lead global clinical study execution across Digital Pathology, IHC/ISH, CDx, and Medical Device programs. You will manage a team of clinical study managers, ensuring regulatory compliance and timely milestones in US and EU markets.

Reporting to the Director, Clinical Development within Global Clinical Affairs, you will collaborate with Clinical Science, Regulatory Affairs, Data Management, Biostatistics,