Danaher

Senior Clinical Study Manager

Danaher$125K — $135K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Healthcare, or related field with 8+ years of related experience, or Master's with 6+ years, or Doctoral degree with 3+ years of related experience.
  • Comprehensive understanding of regulatory requirements and project management principles for clinical studies.
  • Proven experience consulting with management and influencing stakeholders for better outcomes.
  • Strong strategic and tactical planning skills with excellent communication and presentation abilities.

Responsibilities

  • Provide strategic oversight for the operational planning and execution of complex In Vitro Diagnostics (IVD) clinical studies.
  • Communicate potential risks and facilitate key decision-making across cross-functional teams and leadership.
  • Develop and implement comprehensive operational plans for studies, including timelines, budgets, and resource allocation.
  • Conduct regular reviews of clinical study data and performance metrics to ensure data integrity and address quality issues.
  • Act as a key contact for internal and external audits and regulatory inspections.

Benefits

  • Comprehensive medical/dental/vision insurance.
  • 401(k) plan for eligible employees.
  • Paid time off to support work-life balance.
  • Additional benefits that enhance overall quality of life.
Full Job Description
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 and will be an on-site role.

In this role, you will have the opportunity to:
  • 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.


The essential requirements of the job include:
  • 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


It would be a plus if you also possess previous experience in:
  • 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).


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.

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.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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About Danaher

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. More than 275,000 Beckman Coulter systems operate in both Diagnostics and Life Sciences laboratories on seven continents. For more than 75 years, our products have been making a difference in peoples' lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and delivering trusted solutions for research and discovery.

Danaher Careers

Joining Danaher means becoming part of a global team committed to driving growth, innovation, and leadership across various industries. At Danaher, we offer more than just job opportunities; we provide a platform for professional development and personal achievement.

Work You’ll Do

At Danaher, you will engage in work that propels global industries forward through innovation and leadership. Our team at Danaher is dedicated to enhancing the company's impact on science, technology, and healthcare. We believe in fostering a culture of diversity and inclusion, where every team member’s contribution is valued.

Explore Danaher’s Career Opportunities

Whether you are looking for a full-time position, an internship, or a leadership role, Danaher offers a range of employment opportunities to help you advance your career. Our hiring process is designed to identify and attract professionals who are not only skilled but are also passionate about making a difference.

Innovate and Grow with Us

Join a team where innovation is at the heart of everything we do. Danaher’s commitment to innovation drives our leadership in the market and our ability to offer unique solutions to our clients. Here, your skills in technology, problem-solving, and creativity will be honed through challenging projects and a collaborative work environment.

Benefits and Culture

Danaher is dedicated to providing a supportive work environment where careers flourish. Our benefits package is designed to support the health, well-being, and financial security of our employees and their families. From diversity training to professional development programs, we invest in every employee's growth and well-being.

Networking and Professional Development

At Danaher, networking and professional development are part of our DNA. We encourage our employees to connect with colleagues and leaders through various networking events, training sessions, and collaborative projects. This culture of growth and learning helps every team member build a rewarding career filled with exciting new challenges and opportunities.

Join Our Team

Ready to take the next step in your career? Explore the open positions on our Danaher Careers page. Tailor your resume, prepare for your interview, and join a team that’s dedicated to making a real impact. At Danaher, your career is just the beginning of a journey filled with leadership opportunities, innovative projects, and a chance to work with some of the brightest minds in the industry.

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Danaher: Where Careers Grow

At Danaher, we are not just creating job opportunities; we are building careers that make a difference. Join us in our mission to shape the future through innovation, leadership, and growth.
Learn more about Danaher
Size
78,000 employees
Market Cap
$189 billion
Industry
Net Income
$3.6 billion
Founded
1969
5 Year Trend
+11.8%
Revenue
$22.2 billion
NASDAQ

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