Safety Committee Lead

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 youre 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.

• Shape and drive the overarching vision for DSMB and ISM operations to ensure regulatory alignment operational excellence and client satisfaction.
• Serve as the primary liaison to senior-level stakeholders fostering trust through proactive communication and solution-oriented leadership.
• Represent the organization during audits and inspections; collaborate with Quality Assurance to ensure inspection readiness and continuous compliance.
• Monitor milestones and performance indicators to ensure consistent timely delivery across a growing portfolio (170 active DSMBs).
• Identify opportunities to scale operations and reduce manual burden through automation and workflow optimization.

• Lead the development and enforcement of Standard Operating Procedures (SOPs) and Work Practice Guidelines (WPGs)
• Define and implement end-to-end workflows across the full DSMB/ISM lifecycleincluding chartering onboarding data review decision tracking and reporting.
• Ensure all documentation complies with FDA/EMA regulations ICH-GCP standards NIH policies and internal quality systems.
• Identify risk and opportunities related to safety committee operations
• Partner with compliance risk and project management experts to address regulatory considerations and ensure policy adherence.
• Identify and prioritize automation opportunities to improve efficiency reduce manual burden enable scale-up and strengthen audit readiness.

• Oversee DSMB & ISM activities using electronic tracking systems ensuring accurate and timely data input reporting and member lifecycle management.
• Lead or support meeting logistics including agenda coordination calendar invites material distribution and follow-up actions.
• Manage member onboarding and conflict-of-interest documentation
• Ensure consistent use of tools timelines and communications to maintain operational clarity across internal and external stakeholders.
• Prepare routine reports for internal and external stakeholders on DSMB progress meeting schedules member status and compliance metrics.
• Leverage system dashboards and reporting tools to identify trends and inform strategic decision-making related to safety monitoring operations.
• Provide administrative support to ensure proper version control and document storage.

• Supervise and mentor team members providing guidance on issue resolution performance targets and career growth.
• Direct the creation and delivery of training programs workshops and support materials to onboard staff and promote system adoption.
• Cultivate a high-performance culture with a focus on accountability collaboration and continuous learning.

• Executive Communication: Exceptional ability to engage with senior-level stakeholders build relationships and foster collaboration.
• Leadership Excellence: Proven capability to lead diverse teams resolve challenges and drive consensus.
• Strategic Vision: Ability to align operational priorities with broader organizational and client goals.
• System & Data Orientation: Strong proficiency in leveraging electronic systems and data-driven tools for tracking monitoring and decision support across complex operational workflows.
• Adaptability: Demonstrated ability to excel in fast-paced dynamic environments with complex deliverables.
• Interpersonal Savvy: Strong emotional intelligence and diplomacy to effectively manage diverse team and client dynamics.

• Bachelors degree in life sciences biotechnology medical science or a related field (or equivalent experience).
• 8 years of clinical research experience including 2 years in a leadership role.

• Proven success managing multidisciplinary teams related to clinical research initiatives.
• Experience with Safety Monitoring Committees (DSMBs and ISMs) is highly desirable.
• Strong executive communication skills with the ability to engage confidently with senior stakeholders.
• Meticulous attention to detail and a commitment to compliance and quality.
• Proactive self-motivated approach to leadership and problem-solving.
• Comfortable leading remote teams and proficiency with electronic information management systems
• Comfort using Microsoft Office Suite Adobe Acrobat or equivalent SmartSheet or equivalent and electronic project or document management systems.
• Possess DIFZ Core values: Outcomes first never satisfied innovation radical candor and resilience

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 Human Resources at The decision on granting reasonable accommodation will be made on a case-by-case basis.