Beckman Coulter Diagnostics
Life Sciences
SeniorClinicalStudyManager
“Senior Clinical Study Manager at Beckman Coulter Diagnostics. Skills: Clinical study management, IVD clinical studies, Regulatory compliance. Manage clinical trial execution. Provide strategic oversight”
Industry & Context.
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, 8+ years related work experience, Masters with 6+ years experience, Doctoral degree with 3+ years experience, Comprehensive understanding of regulatory requirements, Study execution understanding, Data integrity understanding, Project management principles understanding, Experience working with all levels of management, Consulting with key internal business stakeholders, Proven ability to influence for greater outcome, Strategic planning skills, Tactical planning skills, Written communication skills, Verbal communication skills, Presentation skills
Nice to Have
Experience in study designs diagnostic technologies, Clinical Chemistry experience, Immunoassays experience, Biomarkers experience, Advanced degree in Science, Advanced degree in Healthcare, Advanced degree in Regulatory/Clinical Affairs, Professional certification in Clinical Research
What You'll Do.
Manage clinical trial execution
Provide strategic oversight
Plan clinical studies
Execute clinical studies
Ensure adherence to protocols
Ensure adherence to GCP
Ensure adherence to regulatory requirements
Communicate potential risks
Facilitate key decision-making
Develop study operational plans
Implement study operational plans
Manage study timelines
Manage study resource allocation
Manage risk mitigation strategies
Conduct regular reviews of clinical study data
Review site monitoring reports
Review operational metrics
Ensure data integrity
Address performance issues
Address quality issues
Support internal audits
Support external audits
Support regulatory inspections
Provide documentation
Address audit findings
Address inspection observations
How You'll Work.
Team & Collaboration
Cross-functional teams; Clinical support functions; Leadership communication
Communication Scope
Written communication; Verbal communication; Presentation skills
Process & Methodology
Project management principles
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