Senior Clinical Study Manager

Senior Clinical Study Manager

Responsible for managing clinical trial execution from feasibility assessments through study closeout.

• 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.
• Communicate potential risks and facilitate key decision‑making across cross‑functional teams, clinical support functions, and leadership.
• Develop and implement comprehensive study operational plans, including timelines, budgets, resource allocation, and risk mitigation strategies to ensure efficient and successful study conduct.
• 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.
• 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.

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years related work experience or Master’s with 6+ years of related experience or Doctoral degree with 3+ years of related experience.
• Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, 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 for greater outcome.
• Strong strategic and tactical planning skills along with strong written and verbal communication skills and presentation skills.

• Experience in study designs for diagnostic technologies (IVD) is highly preferred, specifically for Clinical Chemistry, Immunoassays, and/or Biomarkers.
• Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
• Professional certification in Clinical Research (e.g., SoCRA, ACRP).

The annual salary range for this role is $125-135k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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