Associate Director, Data Standards and EDC Programming

Revolution Medicines•Redwood City, CA

8d•$186,000 - $233,000

About The Position

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 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. The position requires practical experience building studies in Medidata Rave and sound judgment about when standards 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 timelines. The role also oversees EDC programming staff and external partners, manages priorities and resources, and maintains standards aligned with CDASH, CDISC controlled terminology, and downstream SDTM requirements. It supports study teams and vendors in applying standards, coordinates cross-functional resolution of data and integration issues, and serves as the EDC programming subject matter expert for audits, inspections, and regulatory submissions.

Requirements

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.

Nice To Haves

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.

Responsibilities

Manage EDC programming staff and external programming partners by assigning work, reviewing deliverables, providing technical guidance, and supporting staff development.
Set priorities and resource plans for EDC programming and data standards work; agree on timelines with study teams, manage competing requests, and escalate 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 effects 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 appropriate internal teams and monitor vendor performance.
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 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 approvals are in place before release.
Maintain version control, change records, release documentation, and traceability for the Global Library and study configurations.
Resolve issues with data transfers, integrations, and reconciliation in collaboration with Data Management, Statistical Programming, IT, and external data providers, including laboratory, imaging, eCOA, and IRT data.
Work with study teams to define EDC reports, metrics, and dashboards; review report-change requests and support development of tools to monitor data and study progress.
Assess Medidata releases and changes to industry standards for their effect on configurations and library components, and plan testing and updates with relevant teams.
Develop and maintain EDC programming SOPs, work instructions, specifications, and training materials; help study teams and vendors apply standards correctly.
Track library-standard use, build timelines, rework, and recurring defects; use findings to improve programming practices and evaluate automation or other tools to 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.