Associate Director, External Data Quality Manager

DirectorDirectorFull TimeRemoteTeam 1,001-5,000Since 1999H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

82 days ago

Salary

$146.6K - $220.0K / year

Bachelor Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

• Serve as a portfolio‑level lead for external data quality and clinical data‑related operational strategy. • Drive consistency of processes, quality expectations, and documentation across studies, assets, and vendors. • Solve complex operational issues by gathering detailed inputs, synthesizing technical and business considerations, formulating data-driven recommendations, securing cross-functional alignment, and leading effective implementation. • Influence portfolio‑level decision making by providing strategic insights on risks, timelines, and data‑dependent operational impacts. • Oversee portfolio‑level strategy for acquisition, integration, and quality oversight of third‑party data (e.g., central/local labs, eCOA, imaging, biomarkers). • Provide expert review of protocol requirements, vendor specifications, and operational data flows. • Collaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, Biostatistics, and Medical Writing to ensure aligned execution and issue resolution. • Drive continuous improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management. • Provide strategic oversight of external vendors handling clinical data; focus on operational performance, quality compliance, and cross‑trial consistency. • Contribute to regulatory submission strategy, ensuring external data and associated processes meet inspection and documentation requirements.

Job Requirements

  • Bachelor’s degree in a scientific, technical, or health-related field; advanced degree (MS, PhD) preferred.
  • Minimum of 10 years of experience in clinical operations, clinical data management, or other related clinical research experience with at least 3–5 years in oversight and leadership roles.
  • Strong understanding of end‑to‑end trial conduct
  • Strong Project Management capability
  • Strategic planning and portfolio thinking
  • Operational excellence and process improvement mindset
  • Cross‑functional alignment and communication
  • Vendor oversight and partnership management
  • Problem solving, critical thinking and decision making
  • Knowledge of EDC systems, ICH‑GCP, GDMP, and regulatory expectations
  • Experience in oncology preferred.

Benefits

  • 401(k) Plan: 100% match on the first 6% of contributions
  • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
  • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
  • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
  • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
  • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Related Categories

Related Job Pages

More Director Jobs

Strategic Accounts Director – Provider Accounts

Garner Health

A better way to get your employees to high-quality doctors.

Director83 days ago
Full TimeRemoteTeam 51-200Since 2019H1B No Sponsor

Strategic Account Director driving success for provider clients in the healthcare space

United States
$170K - $190K / year

Senior Director, Equity

Affirm

We create honest financial products that improve lives.

Director83 days ago
Full TimeRemoteTeam 1,001-5,000Since 2012H1B Sponsor

Senior Director of Global Equity overseeing payroll functions at Affirm

United States
$253K - $355K / year

Director – Veeva Quality Strategy

Veeva Systems

The Industry Cloud for Life Sciences

Director83 days ago
Full TimeRemoteTeam 1,001-5,000H1B Sponsor

Director of Vault Quality Strategy growing Veeva's Quality Cloud customer base

Massachusetts
$125K - $300K / year
Full TimeRemoteTeam 10,001+Since 2020H1B No Sponsor

Director leading supply chain digital architecture at RTX Corporation

Minnesota
$176K - $352K / year