Senior Biomedical Research, Data Governance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the development of policies, processes, and frameworks for research design, data collection, analysis, and dissemination.

• Partner with research consortia, scientific working groups, and institutional collaborators to ensure ethical and responsible research and data sharing.

• Create and implement governance systems to safeguard research participants and uphold scientific integrity.

• Evaluate data sensitivity and design as well as implement data governance strategies, such as data access controls.

• Assess new privacy issues and revise compliance methods accordingly.

• Ensure adherence to ethical, legal, and institutional standards.

• Participate in incident investigations and Corrective Action/Preventive Action (CAPA) plans.

• Monitor activities and provide reports to stakeholders.

• Direct governance initiatives for the responsible use of AI and other emerging technologies.

• Develop and establish data-sharing and governance standards, protocols, training materials, and presentations.

• Cultivate partnerships with internal teams and external collaborators.

• Address data access requests and offer user support.

• Design and manage governance frameworks and data privacy guidelines.

• Oversee custom data governance systems and the execution of complex data-sharing agreements.

• Lead internal and external investigations and contribute to high-level audit reports.

• Develop and negotiate terms for data-sharing agreements.

• Identify gaps in governance and modernize workflows and documentation utilizing AI and emerging technologies.

• Lead privacy and compliance training programs, acting as a subject matter expert.

⛳️ Requirements

• Bachelor’s degree in a relevant field such as life sciences, public health, public administration, or social sciences.

• Over 7 years of professional experience in a research environment involving human biomedical data.

• Familiarity with laws, regulations, and best practices associated with human research data.

• Experience in preparing and submitting Institutional Review Board (IRB) materials, preferably including multi-site protocols.

• Regulatory experience in human subjects research.

• Proficiency with legal language or reviewing data-sharing agreements.

• Background in developing or enhancing Standard Operating Procedures (SOPs) or process documentation.

• Knowledge of incident investigation, root cause analysis, and CAPA plans.

• Strong organizational skills and attention to detail.

• Experience with documentation/task management tools such as Google Suite, MS Suite, Confluence, and Jira.

• Excellent written and verbal communication skills across diverse audiences and mediums.

• Understanding of F.A.I.R. data sharing principles and ethical research considerations for human biomedical research.

• High level of digital literacy and a willingness to learn new software and tools.

• Ability to navigate ambiguity as project and business needs evolve.

• Capacity to maintain focus and concentration during computer-based and reading-intensive tasks.

• Proven ability to work effectively under deadlines.

• Strong problem-solving and analytical capabilities.

• Flexibility to adjust to changing environments, priorities, and multitasking demands.

• Effective verbal and written communication skills.

• Ability to collaborate well within a team and uphold professionalism.

• Commitment to adhering to company policies, procedures, and applicable laws and regulations.

• Travel is required at least twice a year for on-site events in Seattle, Washington.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, AD&D, and long-term disability coverage.

• A robust retirement plan.

• Flexible spending accounts (FSA).

• Paid time off.

• Flexible work arrangements.

• Virtual-first interviews conducted online.