Regulatory Operations & Digital Transformation Lead

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 youre 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

DigitalInfuzionsRegulatory Operations & Digital Transformation Lead provides regulatory and operational leadership across clinical research programs and Data and Safety Monitoring Board (DSMB) activities leveraging deep programanddomainspecific workflow expertise to drive systems modernization process harmonization and technology-enabled transformation across clinical researchoperationssystems 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 programdomainandstakeholderspecific workflows to strengthen and improve operations.

• Serve as a client division lead tofacilitatesmooth transitions todesignatedclinical research systems and technology capabilities coordinating division needs readiness implementation and adoption whilemaintainingcontinuity 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 divisionsidentifyingopportunities to streamline and standardizeworkflowsand reduce inefficient or manual processes.

• Identifyand advance opportunities toleverageAI 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 tomaintainaccuracy as systems and processes evolve.

• Partner with technical and operational leadership to prioritize modernization opportunities and drive initiatives from businessneedand requirements definition through implementation and operational adoption.

• Federal health or research agency experience is stronglydesired including direct NIH support NIH-funded research or experience within NIH-aligned clinical research environments.
  

Requirements

• Bachelors degree in life sciences health sciences information systems business or a related fieldrequired

• 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.

• Experienceidentifyingor implementing AI automation or other emerging technology solutions within regulated or research environments is a plus.

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 The decision on granting reasonable accommodation will be made on a case-by-case basis.