[Remote] Senior Clinical Study Manager at Danaher Corporation

United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Diagnostics, Biotechnology, Life SciencesIndustries

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

Responsibilities

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

Skills

Key technologies and capabilities for this role

Clinical Trial ManagementRegulatory ComplianceStrategic PlanningClinical OperationsStudy ExecutionUS RegulationsEU RegulationsProject Management

Questions & Answers

Common questions about this position

Is this position remote or on-site?

The role is ideally located on-site in Miami, FL, or remote within the USA.

What is the salary range for this Senior Clinical Study Manager position?

This information is not specified in the job description.

What are the essential requirements for this role?

A Bachelor’s degree is required for this position.

What is the company culture like at Danaher Diagnostics?

The culture emphasizes belonging where unique viewpoints matter, continuous improvement through the Danaher Business System, and innovation for tangible impact in diagnostics.

What does the team structure look like for this role?

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.

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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