Regulatory Monitoring & DSMB Ops - Future Opportunities

Regulatory Monitoring & DSMB Ops - Future Opportunities Digital Infuzion is building a pipeline of Regulatory Monitoring & DSMB Operations professionals across multiple levels to support safety oversight within federally funded clinical research portfolios. These roles help ensure participant safety and regulatory compliance by leading or supporting Data and Safety Monitoring Boards (DSMBs), Safety Committees, and related oversight activities. Depending on the level, you may contribute as an individual expert or serve as a people/operations leader. Position Overview These roles support DSMB and Safety Committee operations end‑to‑end and manage safety data review workflows, compliance, SOPs, continuous improvement, tracking, tool evaluation, stakeholder engagement, and oversight quality. Job Responsibilities Support DSMB and Safety Committee operations end‑to‑end (chartering, scheduling, meeting logistics, minutes, action/decision tracking, deliverables, and reporting). Coordinate safety data review workflows (including SAE/AE‑related documentation support) and ensure completeness, quality, and timeliness. Maintain compliance with applicable federal and regulatory expectations (e.g., NIH policies, FDA regulations, OHRP/HHS requirements, and ICH‑GCP). Create, document, and maintain SOPs and Work Practice Guidelines; ensure consistent application across boards and studies. Identify operational gaps and implement continuous improvements that strengthen oversight quality and audit readiness. Maintain forward‑looking tracking (risk logs, compliance trackers, dashboards, document repositories) to ensure transparency and accountability. Evaluate, recommend, and optimize tools/systems used for oversight operations (version control, documentation integrity, reporting cadence). Engage with government stakeholders and internal leadership to provide clear status updates, risks/issues, and mitigation recommendations. Requirements Education: Bachelor’s degree in life sciences, public health, regulatory affairs, or a related discipline (advanced degree a plus for senior levels). Experience (level‑flexible): Progressive clinical research experience supporting regulatory oversight and safety monitoring. DSMB / Safety Monitoring: Demonstrated experience supporting DSMBs, Safety Committees, or safety oversight activities within clinical research programs. Regulatory & Quality: Working knowledge of SAE/AE processes, essential regulatory documentation, and audit‑readiness practices; ability to interpret and apply relevant standards (e.g., ICH‑GCP, federal human subjects protections, and sponsor/agency requirements). Process & Operations: Proven ability to write and maintain SOPs/WPGs, standardize workflows, and improve operational efficiency using metrics and structured problem‑solving. Systems & Documentation: Strong capability with documentation platforms and tracking tools (e.g., SharePoint or similar repositories, dashboards, trackers); disciplined approach to version control and record integrity. Communication: Clear, professional writing and stakeholder communication—comfortable presenting status, risks, and recommendations with confidence. Leadership & Values Fit: Ability to set expectations and deliver feedback with Radical Candor, prioritize outcomes, and remain resilient under tight timelines. Federal portfolio experience: NIH or other federal clinical research experience strongly preferred (especially for mid/senior levels). Equal Employment Opportunity Digital Infuzion does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non‑merit factor per Federal laws. We can provide reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact Talent Acquisition at View email address on click.appcast.io. #J-18808-Ljbffr Digital Infuzion