Job Description
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 Overview
This position reports directly to the Safety Committee Lead and is integral to executing the vision for operational excellence, and continuous improvement in Data Safety Monitoring Board (DSMB) management and operational processes.
We are seeking a Safety Committee Specialist with strong interest in and experience managing all aspects of DSMB management, The SCS must have documented experience in coordinating and moderating DSMB meetings and management of study documents and related processes. Prior experience in clinical research, Phases 1-IV is required. This role will play a critical part in both ensuring regulatory alignment and overseeing the coordination and logistics needed to support DSMB operations for 30 DSMBs within an electronic management system.
This position is ideal for someone who enjoys building structure, thrives in fast-paced environments, and takes pride in ensuring no detail is overlooked in the service of patient safety and clinical research quality.
Key Responsibilities
Regulatory & Compliance Execution
- Assist in the implementation of DSMB-related Standard Operating Procedures (SOPs) and Working Practice Guidelines in accordance with GCP, FDA, EMA, ICH, and NIH standards.
- Maintain and manage accurate documentation for DSMB charters, rosters, COI forms, DSMB summaries / meeting minutes, and regulatory correspondence.
- Support audits and quality checks related to DSMB activity and compliance status.
Coordination & Logistics Support
Lead or support meeting logistics, including agenda coordination, calendar invites, and material distribution for both open / blinded and closed / unblinded data reportsTrack action items, meeting outcomes, and follow-up requests to ensure timely resolution.Coordinate onboarding and conflict-of-interest (COI) documentation for DSMB members and serve as a key point of contact for meeting logistics.Maintain detailed timelines, checklists, and communications to ensure seamless execution of DSMB operations.Support management of DSMB payment processing and contract documentation tracking, where applicable. (This is not currently a function of the SCS role.Operational Support
Maintain meticulous, system-driven records in the electronic DSMB management system (SharePoint and CROMS), ensuring traceability, version control, and real-time visibility of safety committee operations.Prepare routine reports for internal and external stakeholders on DSMB progress, meeting schedules, member status, and compliance metrics.Provide administrative support to ensure proper version control and document storage.Identify risks and opportunities related to safety committee operations.Work with the Safety Committee Lead to identify opportunities to reduce manual burden through automation and workflow optimization.Translate strategic automation and efficiency goals into operational workflows, piloting improvements that reduce administrative burden and enhance accuracy.Act as a tactical liaison between the Safety Committee Lead and study teams, ensuring that logistics and documentation directly support leadership priorities and regulatory timelines.Proactively manage timelines, refine documentation workflows, and flag risks or process gaps to leadership.Collaboration & Communication
Interface with DSMB Chairs, members, study teams, government clients, and internal staff to align logistics, timelines, and expectations.Ability to work in a matrix team environment and across departments / divisions.Ability to partner with DSMB support staff, including Safety Committee Administrators (SCAs).Respond to inquiries related to DSMB coordination, SOPs, and documentation requirements.Training & Documentation
Assist in the development of user-friendly training materials, guidance documents, and process maps.Participate in team training efforts and contribute to onboarding new team members to DSMB workflows and logistics.What You Will Bring to the Role
Strong sense of ownership, responsibility, and teamwork.Proven ability to manage complex timelines, coordinate logistics, and align multiple stakeholders to deliver critical safety committee milestones with precision and efficiency.Working knowledge of regulatory frameworks including GCP, FDA, and ICH, paired with the adaptability to stay current and compliant in a constantly evolving environment.Exceptional organizational and communication skills, embracing radical candor to proactively identify issues, surface insights, and foster trust across diverse teams.Proficiency with Microsoft Office Suite and familiarity with digital project management or document-control systems, with a willingness to explore smarter, faster ways to work.A resilient, team-first approach fueled by curiosity and a drive to continually improve processes in service of advancing clinical research and patient safety.Quickly adopt and optimize new tools and technologies, contributing to a data-driven, automation-enhanced approach to DSMB oversight.Process-oriented with an eye for efficiency, consistently identifying and implementing improvements, including opportunities for automation.Your Experience
Bachelor’s degree in life sciences, biotechnology, medical science, or a related field (or equivalent experience).5+ years of clinical research and / or clinical trial monitoring experience and regulatory-related processes (experience managing DSMBs is required).Knowledge, Skills and Abilities
Proven success working in multidisciplinary teams related to clinical research initiatives, specifically DSMBs.Basic understanding of clinical research, GCP, ICH, and related regulatory guidances.Strong communication skills, with the ability to engage confidently with senior stakeholders.Proven technical and / or medical writing experience, including drafting DSMB summaries, and editing SOPs and guidance documents.Meticulous attention to detail and a commitment to compliance and quality.Excellent time management, critical thinking, andprioritization of tasks skill sets.Ability to interpret and understand medical terminology and handle sensitive and confidential information appropriately.Comfort using Microsoft Office Suite, Adobe Acrobat (or equivalent), and electronic project- or document-management systems.Possess DIFZ core values : Outcomes First, Never Satisfied, Innovation, Radical Candor, and ResilienceDigital 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 HR@digitalinfuzion.com. The decision on granting reasonable accommodation will be made on a case-by-case basis.
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