Regulatory Monitoring & DSMB Operations (Associate–Senior) - Talent Pipeline

Digital Infuzion • Rockville, MD

17d

About The Position

We believe that by equipping researchers with rapid insights and providers with tailored, on-demand data, we can help people lead better, healthier lives. At Digital Infuzion, we harness innovative healthcare solutions and cutting-edge bioinformatics to make meaningful impacts in patient care.
Our team thrives in a creative, open, and growth-oriented environment, guided by our core values:
Outcomes First: Focusing on what matters most and making timely, informed decisions.
Innovative: Embracing creativity and continuous improvement to drive novel solutions.
Radical Candor: Communicating openly and honestly, balancing direct feedback with genuine care.
Never Satisfied: Pursuing excellence and continuous growth beyond the status quo.
Resilient: Adapting and persevering through challenges, turning obstacles into opportunities.
If you're passionate about leveraging technology to improve healthcare and want to work in an environment that values innovation and collaboration, we may have just the opportunity for you.
Position Overview
While this position is not currently open, we are always looking for top talent in this field to join our network for upcoming contract awards and future growth. 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.

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; depth and leadership expectations scale by level.
• 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.

Nice To Haves

• Federal portfolio experience: NIH or other federal clinical research experience strongly preferred (especially for mid/senior levels).

Responsibilities

• Manage and/or 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 as applicable, 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.
• (Mid/Senior levels) Lead or supervise staff supporting monitoring operations; set expectations, coach performance, and reinforce quality standards.

What This Job Offers

• Career Level: Entry Level