Associate Director, Data Standards and EDC Programming

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

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

• 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.

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

• 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.

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

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

• 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.

• 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.

• 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.

• 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.

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

• 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.

• 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.

• 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.

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

• 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.

• Support audits, inspections, and regulatory submissions as the EDC programming subject matter expert, including providing system documentation and explaining programming and validation decisions.

Required Skills, Experience and Education:

• Bachelor’s degree in computer science, Information Systems, Life Sciences, Statistics, or a related discipline with at least 10+ years of relevant pharmaceutical, biotechnology, or CRO experience; or a master’s degree with at least 8+ years of relevant experience.

• At least 8 years of hands-on Medidata Rave programming experience, including at least 4 years building, configuring, and implementing clinical study databases.

• Experience maintaining a Rave Global Library and applying reusable forms, edit checks, custom functions, and other standards across studies.

• Strong working knowledge of Rave Architect, eCRF design, study configuration, edit checks, derivations, and C# custom function programming.

• Experience leading programming teams or managing external programming partners, including planning work, reviewing quality, mentoring staff, and addressing delivery issues.

• Experience working with study teams to translate protocol requirements into EDC specifications and manage study builds, amendments, testing, and production changes.

• Knowledge of CDASH, SDTM, CDISC controlled terminology, and the relationship between data collection, data structures, and submission requirements.

• Working knowledge of GCP, ICH guidelines, 21 CFR Part 11, computerized systems validation, and clinical data integrity requirements.

• Understanding of clinical data flow, external data transfers, reconciliation, and technical troubleshooting across clinical systems.

• Ability to manage several studies and standards projects, make practical technical decisions, and explain issues and options clearly to technical and nontechnical colleagues.

Preferred Skills:

• Medidata Rave Study Builder Certification or advanced training in Rave custom functions and Global Library development.

• Sponsor-side experience managing EDC standards, system configurations, vendor relationships, and programming budgets.

• Oncology experience, particularly early-phase studies, complex visit schedules, and Phase I through Phase III development programs.

• Experience with metadata repositories, CDISC ODM, CDISC Library APIs, or Rave Web Services.

• Experience using SQL, SAS, Python, or reporting tools to support data review, programming, or automation.

• Experience with Rave Safety Gateway or other EDC integrations supporting safety reporting.

• Experience supporting regulatory submissions, audits, or inspections.

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