Lab Data Manager

Lab Data Manager - Oncology (Hybrid)

The Role

We're partnering on a Lab Data Manager opportunity supporting oncology clinical studies, with ownership of local lab reference ranges (LNRs) across trials. This role is highly collaborative and visible, sitting between lab data, clinical data management, and regulatory readiness.

Hybrid model with 3 days onsite per week in either the Bay Area or New Jersey.

Key Responsibilities

• Own end‑to‑end local lab reference range (LNR) management, including QC, issue tracking, and health status monitoring
• Build and load LNR import files into the EDC local lab module and manage change control
• Serve as the SME for lab data/LNRs during audits, inspections, and regulatory submissions
• Partner with Data Management, study teams, sites, and vendors to ensure high‑quality lab data
• Create and maintain lab‑related controlled documents and provide training as needed
• Act as the primary point of contact for all local lab reference range questions

What We're Looking For

• 6+ years of experience in clinical or lab data management
• 3+ years of hands‑on experience managing local lab reference ranges in an EDC system (Veeva preferred)
• Oncology trial experience on the sponsor or CRO side
• Strong understanding of FDA/ICH guidelines, CDISC/CDASH, and submission readiness
• Comfortable owning lab data end‑to‑end and working cross‑functionally

Why This Role

• High ownership and SME‑level responsibility
• Direct involvement in inspection‑ and submission‑ready datasets
• Competitive base salary plus bonus and equity
• Strong benefits package, including:
  • 401(k) with company matching
  • Medical, dental, and vision coverage (heavily employer‑subsidized)
  • Generous PTO and holiday shutdowns
  • Parental leave and wellness benefits
  • On‑site perks when in office