Project Manager

AccuraGen

  • Milpitas, CA
  • 30+ days ago

    Highlights

    The project Manager is responsible for timeline management, milestone tracking, cross-functional coordination, regulatory readiness planning, and risk management. · Experience supporting CLIA/CAP accreditation, LDT development, or regulated laboratory environments preferred.

    Numbers & Facts

    LocationMilpitas, CA

    Description

    Position Overview

    The project Manager is responsible for timeline management, milestone tracking, cross-functional coordination, regulatory readiness planning, and risk management .

    Key Responsibilities

    1. 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.

    2. 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.

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