Senior Biomedical Research, Data Governance

This is a fully remote position, open to applicants anywhere in the world.

📋 Description

• Spearhead the creation of policies, processes, and frameworks that oversee activities such as research design, data collection, analysis, and dissemination.

• Collaborate with research consortia, scientific working groups, and institutional partners to ensure ethical, responsible, and accountable research and data sharing practices. Design, implement, and advocate for governance systems that safeguard the rights and welfare of research participants while maintaining the integrity of the scientific process.

• Drive initiatives that facilitate responsible data sharing by assessing data sensitivity and crafting governance strategies, including data access controls. Oversee the evaluation of emerging privacy issues and develop or enhance compliance methods to meet current demands. (This position does not focus on data engineering or analytics.)

• Ensure compliance with ethical, legal, and institutional standards. Participate in incident investigations and implement corrective actions/preventive action (CAPA) plans. Monitor activities and report findings to stakeholders.

• Lead initiatives in research, the scientific community, and data governance that enable the responsible application of AI and other emerging technologies. Advocate for the integration of AI tools for documentation, process enhancement, and innovative applications within the governance domain.

• Oversee the development and execution of standards for data sharing and governance education. Create and maintain new governance protocols and disseminate updated standards through training materials and presentations.

• Foster governance partnerships with internal teams and external collaborators. Respond to data access requests and provide user support as necessary. Offer guidance to established research communities utilizing standard or innovative data sharing and governance frameworks.

⛳️ Requirements

• Bachelor's degree in a relevant discipline (e.g., life sciences, public health, public administration, social sciences).

• Over 7 years of professional experience in a research environment involving human biomedical data (e.g., clinical research in academic, hospital, pharmaceutical, or similar settings).

• Proven knowledge and experience with the laws, regulations, and best practices related to human research data.

• Experience in preparing materials and submitting to Institutional Review Boards (IRBs), ideally including multi-site protocols. Human subjects research regulatory experience is essential for this role.

• Familiarity with legal terminology or reviewing data sharing agreements.

• Experience in developing and/or refining Standard Operating Procedures (SOPs) or other process documentation for routine tasks.

• Knowledge of incident investigation processes, root cause analysis, and Corrective Action/Preventive Action (CAPA) plans.

• Demonstrated organizational skills and meticulous attention to detail.

• Proficiency 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 coverage.

• Strong retirement plan and flexible spending accounts (FSA).

• Paid time off and flexible work arrangements.