Safety Committee Specialist

Description:

Digital Infuzion is seeking a dedicated and detail-oriented Safety Committee Specialist to support the coordination, compliance, and operational excellence of Data Safety Monitoring Boards (DSMBs) and Independent Safety Monitoring (ISM) processes. This position plays a vital role in advancing clinical research and ensuring patient safety through meticulous execution of regulatory, operational, and logistical tasks.

As a Safety Committee Specialist, you will assist in implementing DSMB-related Standard Operating Procedures (SOPs) and Working Practice Guidelines, ensuring compliance with GCP, FDA, EMA, ICH, and NIH standards. The role involves maintaining accurate documentation including DSMB charters, rosters, conflict of interest (COI) forms, meeting minutes, and regulatory correspondence. You will also provide support for audits and quality checks related to DSMB activity.

The position requires leading or supporting meeting logistics, such as coordinating agendas, sending calendar invites, distributing materials, tracking action items, and managing follow-up requests to ensure timely resolutions. You will coordinate DSMB member onboarding, manage COI documentation, handle payment processing and contract tracking where needed, and maintain detailed timelines and checklists for seamless DSMB operations.

You will prepare routine reports for internal and external stakeholders on DSMB progress, schedules, and compliance metrics while ensuring traceability, version control, and system-driven records in the electronic DSMB management system. Additionally, you will identify operational risks and opportunities, collaborate with the Safety Committee Lead to introduce automation and workflow optimization, and serve as a key liaison between leadership and study teams.

Strong collaboration and communication skills are essential, as you will interact with DSMB Chairs, study teams, government clients, and internal staff to ensure smooth operations. You will also contribute to training, create user-friendly documentation, and support onboarding new team members.

Requirements & Qualifications:

• Bachelor’s degree in life sciences, biotechnology, medical science, or related field (or equivalent experience).

• 5+ years of clinical research experience, preferably involving DSMB operations.

• Knowledge of GCP, FDA, EMA, ICH, and NIH regulatory frameworks.

• Proven ability to manage complex timelines and logistics with precision.

• Proficiency in Microsoft Office Suite and familiarity with digital project-management or document-control systems.

• Strong organizational, communication, and problem-solving skills.

• Ability to manage sensitive and confidential information.

• Core values: Outcomes First, Never Satisfied, Innovation, Radical Candor, and Resilience.