Associate Director, Data Standards and EDC Programming

Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

The Associate Director of Data Standards and EDC Programming is responsible for clinical data collection standards and Medidata Rave programming at Revolution Medicines. The role manages the continued development of the Rave Global Library and oversees study builds, core system configurations, and programming work performed by external partners.

Reporting to the Senior Director, Clinical Data Systems & Ops Ex, the Associate Director works with Clinical Data Management, IT, Statistical Programming, Clinical Operations, and other study team members to plan and deliver EDC work. Responsibilities include maintaining standards, resolving technical issues, managing vendor performance, and overseeing testing and controlled system changes.

This position requires practical experience building studies in Medidata Rave and the judgment to decide when a standard should be used, revised, or adapted for a study. The Associate Director is expected to reduce repeated programming work, improve build quality, and help study teams meet their timelines.

Responsibilities

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Manage EDC programming staff and external programming partners. Assign work, review deliverables, provide technical guidance, and support staff development.

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Set priorities and resource plans for EDC programming and data standards work. Agree on timelines with study teams, manage competing requests, and bring delivery risks and resource needs to management.

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Maintain and expand the Medidata Rave Global Library, including core and oncology eCRFs, edit checks, derivations, custom functions, dictionaries, and study templates.

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Oversee Rave study builds, protocol amendments, database migrations, and production changes. Work with Data Management to confirm requirements and assess the effect of changes on existing data and study processes.

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Review build specifications and programming deliverables and provide hands-on support for complex Rave configurations and C# custom functions.

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Manage core Rave configurations and coordinate user access, site administration, security settings, and study archival activities with IT, Data Management, and vendors.

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Serve as the primary EDC programming contact for Medidata and programming vendors. Review proposals, budgets, contracts, and invoices with the appropriate internal teams, and monitor vendor performance against agreed deliverables.

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Maintain data collection standards aligned with CDASH, CDISC controlled terminology, and downstream SDTM requirements. Work with Statistical Programming and Biostatistics on data structures, annotated CRFs, and mapping considerations.

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Coordinate standards governance reviews, including requests for new forms, changes to existing standards, and study-specific exceptions. Document decisions and track implementation across internal and vendor study builds.

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Oversee testing and validation of library components, study builds, integrations, and system changes. Ensure defects are resolved and required approvals are in place before release.

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Maintain version control, change records, release documentation, and traceability for the Global Library and study configurations.

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Work with Data Management, Statistical Programming, IT, and external data providers to resolve issues with data transfers, integrations, and reconciliation, including laboratory, imaging, eCOA, and IRT data.

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Work with study teams to define EDC reports, metrics, and dashboards. Review requests for report changes and support development of tools that help teams monitor data and study progress.

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Assess Medidata releases and changes to industry standards for their effect on existing configurations and library components. Plan testing and updates with the relevant teams.

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Develop and maintain EDC programming SOPs, work instructions, specifications, and training materials. Help study teams and vendors apply the standards correctly.

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Track use of library standards, build timelines, rework, and recurring defects. Use the findings to improve programming practices and evaluate automation or other tools that reduce manual work.

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Support audits, inspections, and regulatory submissions as

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