Position Overview
The project Manager is responsible for timeline management, milestone tracking, cross-functional coordination, regulatory readiness planning, and risk management .
Key Responsibilities
- Project Planning & Execution
- Maintain integrated project plans across cross-functional teams
- Monitor deliverables and dependencies aligned to product objectives
- Ensure adherence to development timelines and escalate risks as needed
- Facilitate cross-functional project meetings and track action items
- Manage the timeline for CLIA certification and CAP accreditation readiness
- Coordinate cross-functional activities required for inspection preparedness
- Align laboratory operational readiness with accreditation and inspection timelines
- Risk Management & Communication
- Proactively identify project risks and mitigation strategies
- Maintain clear communication across stakeholders
- Serve as central point of coordination for project-level reporting
Qualifications
- Bachelor's degree required; PMP or equivalent certification is a plus
- 3+ years of project or program management experience in biotech, diagnostics, or life sciences
- Strong organizational and communication skills
- Experience supporting CLIA/CAP accreditation, LDT development, or regulated laboratory environments preferred
- Experience supporting clinical development programs in oncology or molecular diagnostics preferred
