Global Senior Manager, Clinical Programs

Regulatory Jobs; United States; Remote; USD 145.000 - 175.000; Vollzeit

Benefits dieser Stelle

Remote work

Bonus potential

Comprehensive benefits

Zusammenfassung

Leica Biosystems, a Danaher operating company, seeks a Senior Manager, Clinical Programs to lead global clinical trial execution for diagnostics products. You will manage a team of clinical study managers, ensure regulatory compliance, and drive milestones across US/EU markets in a fully remote role.

Responsibilities include strategic oversight, cross-functional collaboration, and timelines/budgets management, aligned with ICH-GCP guidelines and SOPs.

Qualifikationen

• Bachelor’s degree in Life Sciences or related field with 7+ years of clinical research experience, or Master/PhD with 5+ years in US/EU trials.
• 4+ years direct leadership experience, including managing clinical study managers.
• Deep understanding of clinical study execution in diagnostics/medical devices/pharma for US/EU markets.

Aufgaben

• Provide strategic oversight for execution of 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, regulatory requirements, and SOPs.
• Manage program timelines, budgets, and resource allocation; mitigate risks.
• Collaborate with Clinical Science, Clinical Operations, Regulatory Affairs, Data Management, and Biostatistics for study conduct and data integrity.
• Oversee site selection and management; ensure performance meets contractual obligations.
• Help develop clinical operations processes to improve efficiency and compliance.

Kenntnisse

Leadership

Communication

Team management

ICH-GCP

Clinical research

Ausbildung

Bachelor’s degree in Life Sciences, Healthcare, or related field

Master’s or Doctoral degree with 5+ years experience

Jobbeschreibung

Leica Biosystems, a Danaher operating company, seeks a Senior Manager, Clinical Programs to lead global clinical trial execution for diagnostics products. You will manage a team of clinical study managers, ensure regulatory compliance, and drive milestones across US/EU markets in a fully remote role.

Responsibilities include strategic oversight, cross-functional collaboration, and timelines/budgets management, aligned with ICH-GCP guidelines and SOPs.