Senior Associate, Clinical Data Standards Management

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $123.9k - $160.4k / year

⏰ Full Time

🟠 Senior

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• 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

• 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

• 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