Program Manager; Reporting, Archiving and Mapping - Hybrid

Responsibilities

• Serve as a Subject Matter Expert in Clinical Programming supporting study build, reporting, and analytics; lead process standardization, simplification, and optimization via best practices and continuous improvement.
• Provide technical leadership/oversight for Clinical Programming deliverables across programs, including eCRF review, specifications, protocol understanding, In-Life Report specifications, and library development; ensure compliance with standards/SOPs; manage timelines and escalate risks related to reporting assets and data flow.
• Partner with study teams, leadership, and external vendors to translate study requirements into high-quality solutions; provide clear technical direction and ensure consistency across deliverables.
• Mentor and develop team members; support hiring and performance feedback; ensure standards for development, documentation, and maintenance of libraries.

• BS in computer science (or equivalent software design exposure).
• 7+ years’ experience implementing data transformations/data flow/loading and reporting (e.g., SQL, PL/SQL, Java, DMW/Veeva, Databricks, Python, Legacy SAS; AI tools such as Claude Code).
• 4 years of project management.
• Strong knowledge of eCRF design, clinical databases/data capture and transfer, ETL/reporting tools, and clinical research development process; EDC/DMS knowledge.
• MS Windows/Office and web application exposure.
• Familiar with drug discovery process, FDA/GxP/ICH requirements, clinical database cleaning, and 21 CFR Part 11.

• Accountability, communication, data analysis/quality assurance/validation/reporting, clinical data standards, GCP/GCDMP, mentoring, project management tools, strategic/team management, AI/generative AI.

Apply via  Posting end date: 04/24/2026 (apply by the day before). Requisition : R391665.

• Eligible for annual bonus and long-term incentive (if applicable).
• Benefits include medical/dental/vision.
• 401(k).
• Paid holidays, vacation, and sick/compassionate days.