Regulatory Operations & Digital Transformation Lead

Digital Infuzion•Rockville, MD

About The Position

Digital Infuzion is seeking a Regulatory Operations & Digital Transformation Lead to provide regulatory and operational leadership across clinical research programs and Data and Safety Monitoring Board (DSMB) activities. This role will leverage deep program and domain-specific workflow expertise to drive systems modernization, process harmonization, and technology-enabled transformation across clinical research operations, systems, and platforms. The Lead will act as a strategic bridge between clinical research and regulatory operations, clients, scientific stakeholders, and technical/development teams. The ideal candidate will translate complex regulatory and operational needs into actionable system requirements and modernization priorities, assisting client organizations in successfully adopting new or enhanced systems and technology capabilities. A strong background in Data and Safety Monitoring Board operations, clinical research regulatory processes, client and cross-functional leadership, and an interest in applying systems, automation, and emerging technologies like AI to improve clinical research operations are essential.

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.

Nice To Haves

Federal health or research agency experience is strongly desired, including direct NIH support, NIH-funded research, or experience within NIH-aligned clinical research environments.
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.

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.