Safety Committee Lead

Company: Digital Infuzion
Location: Rockville
Posted on: May 27, 2025

Job Description:

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 OverviewWe are seeking a Safety Monitoring Board Lead to provide executive leadership in the establishment, management, and oversight of Safety Monitoring Committees, including Data Safety Monitoring Boards (DSMBs) and Independent Safety Monitors (ISMs). This role is critical in ensuring the highest standards of quality, regulatory compliance, and operational excellence across all safety monitoring activities.As leader, you will shape and drive the strategic vision for DSMB/ISM operations, ensuring seamless execution, policy adherence, and continuous process improvement. You will be responsible for interpreting and administering policies, processes, and procedures that govern DSMB/ISM-related workstreams, ensuring alignment with both client expectations and regulatory requirements.You will work in close collaboration with the Safety Committee team to ensure timely, high-quality delivery of all contracted responsibilities. This includes leading efforts related to staffing, training, procedural compliance, and performance optimization. In addition to engaging senior management to standardize internal processes and uphold compliance standards, you will directly support your team in delivering DSMB services for an assigned portfolio of 15 boards, contributing to a growing program currently supporting over 170 active DSMBs.This role demands proactive executive engagement with both internal and external stakeholders, including clients and cross-functional teams. As a key liaison across departments, you will ensure that all safety monitoring activities are strategically aligned, well-coordinated, and flawlessly executed.At its core, this position requires visionary leadership, strategic execution, and an unwavering commitment to delivering the highest-quality safety monitoring services.Key ResponsibilitiesStrategic Leadership

• 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.Process & Compliance Management
  • 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 lifecycle-including 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.Operational Execution & Support
    • 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.Training and Capacity Building
      • 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.What You Will Bring to the Role
        • 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.Your Experience
          • Bachelor's 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.Knowledge, Skills and Abilities
            • 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.This role offers a unique opportunity to lead impactful initiatives, shape strategic processes, and ensure the integrity of safety monitoring practices in clinical research. If you bring passion, expertise, and a collaborative spirit, we encourage you to apply!
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Keywords: Digital Infuzion, Frederick , Safety Committee Lead, Professions , Rockville, Maryland