The project Manager is responsible for timeline management, milestone tracking, cross-functional coordination, regulatory readiness planning, and risk management .
· 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.
· Proactively identify project risks and mitigation strategies.
· Maintain clear communication across stakeholders.
· Serve as central point of coordination for project-level reporting.
· 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.
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