Position Overview Digital Infuzion's Regulatory Operations & Digital Transformation Lead provides regulatory and operational leadership across clinical research programs and Data and Safety Monitoring Board (DSMB) activities, leveraging deep program and domain specific workflow expertise to drive systems modernization, process harmonization, and technology-enabled transformation across clinical research operations, systems and platforms.
This role serves as a strategic bridge between clinical research and regulatory operations, client and scientific stakeholders, and technical/development teams. The Lead translates complex regulatory and operational needs into actionable system requirements and modernization priorities while helping client organizations successfully transition to and adopt new or enhanced systems and technology capabilities.
The ideal candidate brings deep knowledge of Data and Safety Monitoring Board operations and clinical research regulatory processes, strong client and cross-functional leadership capabilities, and an interest in applying systems, automation, and emerging technologies such as AI to improve how clinical research operations are delivered and supported.
Job Responsibilities - Provide regulatory and operational leadership across clinical research and DSMB activities, applying deep knowledge of program, domain and stakeholder specific workflows to strengthen and improve operations.
- Serve as a client division lead to facilitate smooth transitions to designated clinical research systems and technology capabilities, coordinating division needs, readiness, implementation, and adoption while maintaining continuity of regulatory and DSMB operations.
- Translate regulatory, DSMB, and division-specific operational needs into clear business and system requirements, priorities, and enhancements for technical/development teams.
- Lead process modernization and harmonization efforts across programs and divisions, identifying opportunities to streamline and standardize workflows and reduce inefficient or manual processes.
- Identify and advance opportunities to leverage AI, automation, and other technology capabilities to improve regulatory operations, workflows, and service delivery.
- Lead division-level change management and adoption activities to ensure new systems, system enhancements, and redesigned processes are effectively introduced, adopted, and sustained.
- Serve as a strategic bridge among clinical research and regulatory operations, division and scientific stakeholders, and technical/development teams.
- Lead the development, maintenance, and validation of system documentation, training materials, user guidance, and related resources to ensure content accurately reflects system functionality, regulatory and operational workflows, and stakeholder needs; partner with technical and operational teams to maintain accuracy as systems and processes evolve.
- Partner with technical and operational leadership to prioritize modernization opportunities and drive initiatives from business need and requirements definition through implementation and operational adoption.
- Federal health or research agency experience is strongly desired, including direct NIH support, NIH-funded research, or experience within NIH-aligned clinical research environments.
Requirements - Bachelor's degree in life sciences, health sciences, information systems, business, or a related field required
- 7+ years of experience supporting clinical research regulatory operations, DSMB/DSMC activities, clinical research operations, or related environments.
- Demonstrated knowledge of DSMB operations, regulatory workflows, and clinical research processes.
- Experience leading or supporting systems implementation, process modernization, continuous improvement, or digital transformation initiatives.
- Experience translating complex operational or regulatory workflows into business and system requirements for technical/development teams.
- Demonstrated ability to lead cross-functional initiatives involving scientific, regulatory, operational, and technical stakeholders.
- Experience leading change management, stakeholder engagement, and adoption of new systems, processes, or workflows.
- Familiarity with clinical research regulations, quality expectations, and documentation requirements, including GCP and other applicable regulatory frameworks.
- Experience supporting federal or research clients and working within contract-driven delivery environments preferred.
- Experience identifying or implementing AI, automation, or other emerging technology solutions within regulated or research environments is a plus.
