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Senior Clinical Study Manager
Danaher Corporation. Manage overall clinical execution of pre-clinical and clinical trials across a program .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing clinical trials, ensuring protocol compliance, and overseeing clinical staff while maintaining study documentation and budget management. Proven ability to collaborate with cross-functional teams and provide mentorship in a clinical research environment.
Highest-signal resume keywords
Clinical Trial ManagementFDA Regulatory RequirementsClinical Research Associate ExperienceStudy Management ExperienceIn Vitro Diagnostic Clinical Trials
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ExecutionStudy Documentation DevelopmentBudget ManagementRisk ManagementPerformance Tracking
Soft Skills
LeadershipMentorshipCollaborationCommunication
Industry Keywords
Clinical ResearchMedical DeviceBiotechnologyPharmaceuticalInfectious DiseasesOncology
About the role
Key responsibilities & impact- Manage overall clinical execution of pre-clinical and clinical trials across a program
- Lead end-to-end clinical trial execution from planning and site selection through enrollment, monitoring, and closeout
- Ensure specimen and study-material readiness and accountability
- Oversee clinical staff and coordinate sites, CROs, vendors, and external laboratories
- Develop and maintain study documentation and oversight records
- Ensure protocol compliance, traceability, inspection readiness, and risk and issue management
- Manage clinical trial budgets, resources, timelines, and milestones
- Track performance against plans and recommend adjustments
- Partner with executive leadership and cross-functional teams to coordinate data review, study completion, decisions, and progress reporting
- Provide oversight, supervision, and mentorship to associates assigned to the project
Requirements
What you’ll need- Bachelor’s degree in a scientific discipline or equivalent experience
- 8+ years of clinical research experience in the medical device (IVD preferred), biotechnology, or pharmaceutical industries
- Working knowledge of FDA regulatory requirements related to clinical research
- Up to 20% travel
- At least 3 years of clinical research associate (CRA) experience and 3 years of study management experience (plus)
- Experience with in vitro diagnostic clinical trials (plus)
- Experience with clinical trials in infectious diseases and/or oncology (plus)
Benefits
Comp & perks- Bonus/incentive pay eligibility
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Flexible, remote working arrangements for eligible roles
- Remote work from home
- Career growth and development opportunities