Provide strategic leadership for clinical and external data reporting across clinical development unit (CDU) programs.
Focus on the creation, standardization, and delivery of clinical data programming, external data reconciliation, and reporting deliverables across portfolio.
Accountable for the oversight and execution of all data management programming deliverables at the portfolio level.
Ensure alignment with study data review plans (DRP), study milestone needs, operational metrics, and regulatory requirements.
Manage internal teams and external vendors, ensuring study milestones are met while safeguarding data quality, integrity, and compliance with global regulatory standards.
Emphasize cross-functional collaboration, deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems.
Drive strategic leadership with full accountability for the planning, execution, and delivery of high-quality clinical data management programming deliverables across the portfolio of clinical development units.
Provide comprehensive oversight of clinical programming and visualization outputs that reveal key insights to support clinical data review.
Establish robust data reporting standards, implement scalable programming strategies, and optimize workflows incorporating automation.
Lead continuous improvement initiatives to modernize clinical data reporting workflows through standardization, process optimization, and automation.
Ensure inspection readiness and regulatory compliance of programming documentation; contribute to internal audits and health authority inquiries.
Establish and monitor KPIs to track performance and conformance with programming standards.

Requirements

Demonstrated ability to oversee the development, validation, and delivery of clinical data management programming and visualization outputs to cross-functional teams across drug development programs.
Experience in transforming raw clinical data, external data handling, processing, validation, and reconciliation outputs into actionable insights to ensure data accuracy and quality in compliance with industry standards.
Demonstrated ability to function as a clinical data management programming and reporting SME in solving complex issues and guiding internal teams and external vendors for successful outcomes.
Demonstrated ability to build relationships and collaborate across diverse business units including Clinical Data Management, Clinical Development, Precision Medicine, Imaging, and GDIT.
Expertise in managing and reconciling clinical eCRF and external data types including PK, ADA, Biomarker, Imaging, ECG, etc., to ensure data accuracy, integrity, and regulatory compliance.
Proven experience in clinical data operations, clinical data management, reporting, and analytics within a pharmaceutical, biotech, or clinical research organization.
Knowledge of clinical data management principles, technologies, data extraction, transformation, and integration, programming methods and techniques, regulations and best practices, including 21 CFR Part 11, ICH-GCP, and CDISC standards -- related to data acquisition, processing, handling, and reporting.
Knowledge and expertise in industry standard reporting and data visualization tools including SAS, R, JReview, Spotfire, Tableau, Power BI, and R Shiny to drive operational excellence for clinical data management reporting.
Excellent interpersonal, oral, and written communication skills.
Ability to adjust in a fast-paced environment.
May require up to 25% travel.
BS/MS + 12+ years leadership experience

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical data management programmingdata reconciliationdata validationdata visualizationdata extractiondata transformationdata integrationprogramming methodologiesKPI monitoringregulatory compliance

Soft skills

strategic leadershipcross-functional collaborationrelationship buildingproblem solvingcommunicationadaptabilityoversightcontinuous improvementteam managementprocess optimization

Certifications

BSMS