OneTrust

Director of Safety Data Operations – Governance

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Irvine • California • United States

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Salary

💰 $164,000 - $282,900 per year

Job Level

Lead

About the role

  • Identify internal and external data sources relevant to patient safety, including but not limited to clinical trials, preclinical studies, and post-market surveillance.
  • Secure access to these data sets in collaboration with cross-functional teams (R&D, Clinical, Regulatory, Quality, IT, Legal).
  • Develop and implement a governance framework for data use within the EP Organization.
  • Ensure compliance with data privacy, security, and regulatory standards.
  • Maintain documentation of data sources, ownership, and usage guidelines.
  • Partner with Medical Safety Officer, Medical Affairs, Clinical Operations, R&D, Quality, Epidemiology, and Data Science teams to integrate data for safety signal detection and risk assessment.
  • Support development of dashboards and analytics tools to monitor patient safety trends.
  • Act as a liaison between Medical Safety, Medical Affairs, Clinical Operations, Regulatory Affairs, R&D, Quality, Legal and IT to ensure seamless data flow.
  • Provide training and guidance on data governance best practices.
  • Develop KPIs and metrics to measure data quality and governance effectiveness.
  • Lead audits and compliance checks related to data governance.
  • Support strategic initiatives for global harmonization of safety data standards.

Requirements

  • Bachelor’s, Master’s or PhD degree in Life Sciences or related field.
  • Experience in data governance, clinical data management, or pharmacovigilance.
  • Strong understanding of regulatory requirements for clinical and post-market data.
  • Expertise in integrating diverse data sources and leveraging analytics for safety and regulatory decision-making.
  • Strong track record of cross-functional leadership and collaboration.
  • Excellent communication and stakeholder management skills.
Benefits
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Applicant Tracking System Keywords

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Hard Skills & Tools
data governanceclinical data managementpharmacovigilancedata integrationanalyticsKPI developmentmetrics measurementauditcompliance checks
Soft Skills
cross-functional leadershipcollaborationcommunicationstakeholder managementtrainingguidance