Senior Associate, Clinical Data Standards Management

Gilead Sciences

. Support development and maintenance of global clinical data standards and operational data mappings .

Posted 9/17/2026full-timeRemote • United StatesSenior💰 $123,930 - $160,380 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Clinical Data Standards development, including CDISC standards (CDASH, SDTM, ADaM), with a strong focus on global library development and compliance with regulatory requirements. Proficient in EDC programming, particularly with Medidata RAVE, and skilled in cross-functional collaboration to enhance operational excellence.

Highest-signal resume keywords

Clinical Data Standards DevelopmentMedidata RAVE EDC ProgrammingCDISC Standards KnowledgeGlobal Library DevelopmentRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CDISC StandardsEDC ProgrammingGlobal Library DevelopmentCRF DesignData Collection StandardsQuality ChecksProcess ImprovementImpact AnalysisChange ManagementIssue Resolution

Soft Skills

Strong CommunicationCross-Functional CollaborationDetail-Oriented

Tools & Technologies

Medidata RAVETrialGridAzureSmartsheetSharePointVeeva Vault

Industry Keywords

GCPICHFDAEMARegulatory Requirements

Tech Stack

Tools & technologies

AzureVault

About the role

Key responsibilities & impact

Support development and maintenance of global clinical data standards and operational data mappings
Apply CDISC standards, including CDASH and SDTM controlled terminology, in standards development
Develop and maintain global library objects, including eCRFs, edit checks, and dynamics
Assist in regular releases of the Global Library Volume (GLV)
Contribute to CRF Completion Guidelines development
Work across Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, and Veeva Vault to support GLV development, maintenance, and releases
Support consistency and adherence to Kite standards across programs and portfolios
Support Standards Core Committee and Standards Governance Committee activities
Prepare materials, document decisions, and follow up on action items
Partner with functional stakeholders to support standards adoption
Identify and suggest process improvements and support standards-related initiatives
Ensure compliance with regulatory requirements, industry standards, GCP/ICH guidelines, and internal procedures
Provide study support during initial EDC builds, including standards implementation, change management, issue resolution, impact analysis, solution proposals, and escalation
Execute assigned global library build and maintenance activities
Perform quality checks to ensure standards implementation aligns with defined specifications
Document standards release activities

Requirements

What you’ll need

Doctorate and Clinical Data Standards or EDC Programming experience
OR Master’s and 3+ years of Clinical Data Standards or EDC Programming experience
OR Bachelor’s and 5+ years of Clinical Data Standards or EDC Programming experience
Strong desire and passion to work in Clinical Data Standards development
Demonstrated interest in process improvement and operational excellence
Working knowledge of CDISC standards (CDASH, SDTM, ADaM)
Experience programming in Medidata Rave EDC
Experience with Medidata Rave modules including Rave Coder, Targeted SDV (TSDV), ePRO, Lab Admin, Rave Safety Gateway (RSG), Core Configuration and IRT Integrations
Experience in global library development
Understanding of clinical trial data collection and CRF design
Understanding of clinical data management processes including query management, site concerns, and data collection standards
Familiarity with FDA, EMA, ICH, and GCP requirements
Working knowledge of regulatory requirements and industry guidance
Strong communication and cross-functional collaboration skills
Detail-oriented with ability to ensure consistency across studies

Benefits

Comp & perks

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance
Benefits package