• Providing medical and scientific oversight for clinical trials, ensuring the safety of subjects and the integrity of trial data. • Collaborating with clinical operations, regulatory, and safety teams to drive the successful execution of early phase clinical studies. • Developing and reviewing clinical study protocols, study reports, and other key study documents. • Interpreting clinical trial data and providing medical insights to inform decision-making and guide clinical development strategies.

• Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making • Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement • Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk • Drive initiatives to ensure continuous inspection readiness across clinical studies • Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews • Support development of inspection storyboards and response strategies when needed • Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance • Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations • Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs • Participate in vendor governance meetings and performance reviews • Identify trends or risks in vendor performance and recommend mitigation strategies • Review and track vendor QEs • Develop processes for oversight of monitoring activities conducted by CROs • Review monitoring oversight plans, reports, and monitoring metrics • Assess monitoring quality and compliance with monitoring plans • Identify monitoring gaps and collaborate with study teams to address them • Support identification and management of investigator or site non-compliance • Assist study teams in evaluating protocol deviations and escalation needs • Help develop remediation strategies for significant compliance issues • Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations • Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews • Track CAPA effectiveness and ensure timely closure • Identify recurring issues and support continuous improvement initiatives • Partner with QA to support internal and external GCP audits • Assist with audit preparation and documentation review • Support study teams in addressing audit findings • Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs • Identify knowledge gaps and support development of compliance training programs • Contribute to SOPs, guidance documents, and best practice materials.

• Own customer implementations from contract signature through go-live and post-implementation transition. • Lead complex enterprise healthcare technology deployments involving multiple stakeholders, integrations, and workstreams. • Build and scale implementation methodologies, governance processes, tools, and delivery standards. • Partner closely with Product, Engineering, Sales, Customer Success, and Support teams to ensure successful customer outcomes. • Serve as the executive escalation point for implementation risks, issues, and customer concerns. • Establish implementation KPIs, capacity planning processes, and delivery metrics. • Recruit, mentor, and develop implementation team members while maintaining direct involvement in strategic deployments.

• Lead and develop a set of managers running multi-disciplinary teams of project managers, implementation consultants, and technical staff across healthcare product lines • Set team strategy for project planning, staffing, and resource allocation across concurrent NetMenu and Quickcharge engagements • Ensure the team delivers professional services to healthcare clients, meeting established goals for utilization, revenue, and customer satisfaction • Guide implementation teams through the complexity of clinical environments, including EHR integrations (e.g., Epic/HL7), diet order workflows, and healthcare payment systems • Serve as a mentor and escalation point internally and externally; step into a client-facing role for strategic accounts to ensure satisfaction • Partner with Sales, Solution Engineering, and Client Management to ensure successful sales and implementations, where expectations are properly set around delivery timelines, scope, and readiness • Establish and manage third-party partnerships to supplement core staff during peak periods • Drive process improvement and efficiency gains across the team’s delivery model, with particular attention to the regulatory and patient safety demands of healthcare environments