Note: The job is a remote job and is open to candidates in USA. Leica Biosystems Imaging, Inc. (Leica Biosystems) is hiring a Senior Manager, Clinical Programs to oversee global clinical trial execution supporting Danaher Diagnostics. The role leads clinical study managers and drives strategic study operations, regulatory compliance, and delivery of key clinical milestones.
Responsibilities
- Provide strategic oversight and guidance for execution of multiple clinical studies within assigned programs, for Digital Pathology, and Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx), and Medical Device
- Lead, mentor, and manage a team of clinical study managers, fostering their professional development and ensuring high-quality study execution standards
- Ensure studies are conducted in accordance with ICH-GCP guidelines, regulatory requirements, standard operating procedures (SOPs), and study protocols
- Manage program-level timelines, budgets, and resource allocation, proactively identifying and mitigating risks to study execution
- Collaborate closely with cross-functional teams (e.g., Clinical Science, Clinical Operations, Regulatory Affairs, Data Management, Scientific Affairs, Biostatistics) to ensure seamless study conduct and data integrity
- Oversee site selection and management for clinical trial activities, ensuring performance meets contractual obligations and quality standards
- Contribute to the development and implementation of clinical operations processes and best practices to enhance efficiency and compliance
Skills
- Bachelor's degree in Life Sciences, Healthcare, or a related field with 7+ years' experience in clinical research, specifically with significant experience in US and/or EU trials, or a Masters or Doctoral degree with 5+ years of same experience
- 4+ years direct leadership experience, including experience managing clinical study managers
- In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets
- Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation
- Ability to critically review and interpret scientific and clinical trial data, and oversee the scientific aspects of study protocols and reports
- Excellent leadership, communication (written and verbal) and interpersonal skills for managing a team and collaborating with cross-functional stakeholders
- Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Digital Pathology and Immunohistochemistry (IHC) & In Situ Hybridization (ISH)
- Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs
- Professional certification in Clinical Research (e.g., SoCRA, ACRP)
Benefits
- This position is eligible for a remote work arrangement in which you can work remotely from your home.
- Bonus/incentive pay.
- Paid time off.
- Medical, dental, and vision insurance.
- 401(k).
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