Safety Committee Specialist, DSMB

Digital Infuzion; Rockville (MD); On-site; USD 95,000 - 125,000; Full time

Job summary

Digital Infuzion in Rockville, MD, is seeking a Safety Committee Specialist (SCS) focused on clinical trial safety and DSMB coordination. You will oversee DSMB operations for a large portfolio, ensuring regulatory alignment and meticulous logistics across meetings, charters, and documentation.

You’ll report to the Director of Clinical Research Solutions and contribute to building robust processes, training materials, and timely safety reporting, with emphasis on patient safety and research

Qualifications

• Bachelor’s degree in life sciences or related field (or equivalent experience).
• 5+ years of clinical research experience and/or clinical research logistics.
• 2+ years of direct DSMB experience (coordination, documentation, meeting support).
• Strong working knowledge of regulated documentation practices, including version control and audit readiness.
• Exceptional written and verbal communication skills with ability to produce regulator-ready documentation.
• Strong attention to detail, organization, and ability to manage multiple deadlines.

Responsibilities

• Serve as primary SME for the DSMB portfolio and coordinate logistics.
• Assist implementation of DSMB SOPs and WPGs per GCP, FDA, EMA, ICH, NIH standards.
• Maintain documentation for DSMB charters, rosters, COI forms, minutes, and letters.
• Support audits and quality checks related to DSMB activity and compliance.

Skills

Communication

Attention to detail

Project coordination

Teamwork

Regulatory knowledge

Documentation

Education

Bachelor’s degree in life sciences

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:

We are seeking a Safety Committee Specialist (SCS) with a strong interest in clinical trial safety, regulatory compliance, and the coordination of Data and Safety Monitoring Boards (DSMBs). This role will play a critical part in both ensuring regulatory alignment and overseeing the detailed coordination and logistics needed to support DSMB operations for 30 DSMBs within an electronic management system.

Reporting to the Director of Clinical Research Solutions, this SCS 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 research quality.

Core Responsibilities:

Regulatory & Compliance Execution

• Serve as the primary point of contact and subject matter expert for the DSMB portfolio.
• Assist in the implementation of DSMB-related Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) in accordance with GCP, FDA, EMA, ICH, and NIH standards.
• Maintain and manage accurate documentation for DSMB charters, rosters, COI forms, meeting minutes, decision letters, and regulatory correspondence.
• Support audits and quality checks related to DSMB activity and compliance status.

DSMB Leadership

• Serve as the primary representative for assigned DSMBs including internal and external stakeholders.
• Lead meeting logistics, including agenda coordination, calendar invitations, material distribution.
• Track and lead action items, meeting outcomes/outputs, 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.
• Interface with DSMB Chairs, members, study teams, the government client, and internal staff to align on logistics, timelines, and expectations.
• Respond to inquiries related to DSMB coordination, SOPs, and documentation requirements.

Operational Support

• Maintain meticulous, system-driven records in the electronic DSMB management system, 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.
• Identify, escalation and provide potential solutions to risks and opportunities related to safety committee operations.
• Translate strategic direction into action by proactively managing timelines, refining documentation workflows, and flagging risks or process gaps to leadership.

Training & Documentation

• Assist in the development of user-friendly training materials, guidance documents, and process maps.
• Participate in team meetings and training efforts as well as contribute to onboarding new team members to DSMB workflows and logistics.

Required Qualifications:

• Bachelor’s degree in life sciences, biotechnology, medical science, or a related field (or equivalent experience).
• 5+ years of clinical research experience and/or clinical research related logistics.
• 2+ years of direct DSMB experience (coordination, documentation, meeting support).
• Strong working knowledge of regulated documentation practices, including version control, controlled records, and audit readiness.
• Exceptional written and verbal communication skills with the ability to produce clear, structured, regulator-ready documentation.
• Strong attention to detail, organization, and ability to manage multiple deadlines in parallel.
• Strong sense of ownership, responsibility, and teamwork.
• Proven ability to manage complex timelines, coordinate logistics, and align multiple stakeholders to drive forward critical safety committee milestones with precision and efficiency.
• A resilient, team-first approach fueled by curiosity and a drive to continually improve processes in service of advancing clinical research and patient safety.

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 Talent Acquisition at [e-mail]. The decision on granting reasonable accommodation will be made on a case-by-case basis.