Senior Clinical Study Manager

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

Within Danaher the work our diagnostic businesses do saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Were accelerating the development of cutting-edge diagnostics to solve some of the worlds most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. Were bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together were expanding access to precision diagnostics for millions of people worldwide - and were using our unmatched global scale and proven playbook to make it happen from hospital labs to mobile clinics. By helping providers patients and families get faster more precise diagnostic results were improving treatment options and saving lives.

Learn about the Danaher Business System which makes everything possible.

The Senior Clinical Study Manager is responsible for clinical trial execution within the US and EU regions for Danaher Diagnostics. This role will specifically support Beckman Coulter Diagnostics and Life Sciences an operating company of Danaher Diagnostics. You will be responsible for driving strategic operational execution ensuring regulatory compliance and achieving key milestones for critical clinical studies in these vital markets.

This position reports to the Clinical Affair Manager of LS hem and UA and is part of the Danaher Diagnostics CCOE (Clinical Center of Excellence) within the Clinical Development team for Beckman Coulter Inc. organization and will be ideally located on-site in Miami FL or remote within the USA.

In this role you will have the opportunity to:

• Provide strategic oversight for planning and executing complex IVD clinical studies ensuring compliance with protocols GCP and regulatory requirements.
• Manage site and vendor selection contracts and performance metrics to align with study objectives and SOPs.
• Develop and implement operational plans including timelines budgets resource allocation and risk mitigation strategies.
• Maintain effective communication with investigators site staff internal teams and external partners to ensure smooth study progress and issue resolution.
• Review clinical study data to ensure integrity and address issues contributing to the development of essential study documents and providing crucial support during internal and external audits and regulatory inspections.

The essential requirements of the job include:

• Bachelors 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 Hematology Urinalysis Microbiology and/or Flow Cytometry.
• Advanced degree in Science Healthcare or Regulatory/Clinical Affairs
• Professional certification in Clinical Research (e.g. SoCRA ACRP).

Within Danaher Diagnostics we offer a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Within Danaher Diagnostics we believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.

The annual salary range for this role is $120000 - $160000. 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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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- or .