Hybrid Director of Safety Data Operations – Governance

at OneTrust

• Job title: Director of Safety Data Operations – Governance
• Job type: Full Time
• Experience level: Lead
• Salary: $164,000 - $282,900 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Irvine, United States

About the role

• Director of Safety Data Operations and Governance supporting Electrophysiology business in healthcare innovations. Responsible for organizing and establishing governance structures for patient safety data sources.

Responsibilities

• 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

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year