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AccuraGen

Posted 4 months ago

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Project Manager

Milpitas, California, United StatesOn-siteFull-time

AI Summary

Project Manager coordinates timelines, risks, and cross-functional activities to support regulatory readiness and accreditation efforts in biotech settings.

About this role

Title: Project Manager - AccuraGen

URL Source: https://apply.workable.com/j/D2184CF2F5

Markdown Content:

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.

Skills

CAP AccreditationCapacity PlanningCLIAClinical DevelopmentCross-functional CoordinationExecutionInspection PreparednessLDT DevelopmentMilestone TrackingMolecular DiagnosticsOncologyProject ManagementProject PlanningRegulatory ComplianceRegulatory PlanningRegulatory ReadinessRisk ManagementStakeholder CommunicationTimeline Management

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