Senior Clinical Study Manager

About the role

The Senior Clinical Study Manager is responsible for managing clinical trial execution from feasibility assessments through study closeout. This position reports to the Senior Manager Clinical Programs and is part of the Clinical Development Department located in Chaska, MN.

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.
• 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.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 8+ years related work experience or Masters 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.
• Previous experience in study designs 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).

Qualifications

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Benefits

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 range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Pay

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

Schedule

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.