Note: The job is a remote job and is open to candidates in USA. Leica Biosystems, a part of Danaher Corporation, is committed to advancing cancer diagnostics and improving lives. They are seeking a Senior Clinical Study Manager to oversee clinical trial execution, ensuring compliance with regulatory requirements and quality standards while collaborating with internal and external partners.
Responsibilities
- 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 - this includes the development and writing of clinical study protocols, informed consent forms, and other essential study documents, ensuring scientific rigor and operational feasibility
- 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. The individual will 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
Skills
- 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
- Ability to work in a global environment
- 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)
Benefits
- Bonus/incentive pay
- Paid time off
- Medical/dental/vision insurance
- 401(k) to eligible employees
Company Overview
Leica Biosystems develops laboratory workflow solutions for anatomic pathology involved in the advancement of cancer diagnostics. It is a sub-organization of Danaher. It was founded in 1989, and is headquartered in Nußloch, Baden-Wurttemberg, DEU, with a workforce of 1001-5000 employees. Its website is http://www.leicabiosystems.com/.