Senior Biomedical Research, Data Governance

Role Overview

• Lead the development of policies, processes, and structures that guide and oversee activities such as research design, data collection, analysis, and dissemination.
• Collaborate with research consortia, scientific working groups, and institutional partners to ensure the ethical, responsible, and accountable conduct of research and data sharing. . Design, implement, and champion governance systems that protect the rights and welfare of research participants and preserve the integrity of the scientific process.
• Lead initiatives that enable responsible data sharing by evaluating data sensitivity, and designing and applying governance approaches, such as data access controls . Lead the assessment of emerging privacy considerations and develop or update compliance methods to address current needs. (This is not a data engineering or analytics role.)
• Ensure adherence to ethical, legal, and institutional requirements. Contribute to incident investigations and the implementation of corrective actions/preventative action (CAPA) plans. Monitor activities and report to stakeholders.
• Lead research, scientific community, and data governance initiatives addressing and enabling the responsible application of AI and other developing technologies. Promote the use of AI tools for documentation, process improvement, and novel uses within the governance field.
• Lead the development and implementation of standards for data sharing and governance education. Develop and sustain new governance protocols and disseminate/socialize updated standards through training materials and presentations.
• Lead governance partnerships with internal teams and external collaborators. Respond to data access requests and provide user support, as needed. Advise established research communities using standard or novel data sharing and governance framework approaches.

Requirements

• Bachelor’s degree in a relevant field (e.g., life sciences, public health, public administration, social sciences)
• 7+ years of professional experience in a research setting involving human biomedical data (e.g., clinical research within an academic, hospital, pharmaceutical industry, or related setting).
• Demonstrated knowledge and experience with the laws, regulations, and best practices related to working with human research data.
• Experience preparing materials and submitting to Institutional Review Boards (IRBs), preferably including multi-site protocols. Human subjects research regulatory experience is foundational to the role.
• Experience with legal language or data sharing agreement review.
• Experience developing and/or improving Standard Operating Procedures (SOPs) or other process documentation for day-to-day tasks.
• Knowledge of incident investigation processes, root cause analysis, and Corrective Action/Preventive Action (CAPA) plans.
• Demonstrated organizational skills and attention to detail.
• Experience with documentation/task management tools (e.g., Google Suite, MS Suite, Confluence, Jira).

Benefits

• Comprehensive medical, dental, vision, life, AD&D, and long-term disability.
• Robust retirement plan and flexible spending accounts (FSA).
• Paid time off and flexible work arrangements.