Note: The job is a remote job and is open to candidates in USA. Kite is a biopharmaceutical company focused on developing innovative cancer immunotherapies, including CAR T-cell therapies. The Senior Associate, Clinical Data Standards Management supports the development, implementation, maintenance, and governance of global clinical data standards across clinical programs, collaborating with cross-functional teams to ensure consistent, high-quality, and regulatory-compliant implementation.
Responsibilities
- Support development and maintenance of global clinical data standards and operational data mappings
- Apply CDISC standards (CDASH, SDTM controlled terminology) in standards development
- Develop and maintain global library objects (eCRFs, edit checks, dynamics etc.)
- Assist in regular releases of the Global Library Volume (GLV)
- Contribute to CRF Completion Guidelines development
- Work within multiple technologies to promote the development, maintenance and releases of the GLV (Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, Veeva Vault, etc.)
- Support consistency and adherence to Kite standards across programs and portfolios
- Support Standards Core Committee (SCC) and Standards Governance Committee (SGC) activities including preparation of materials, documentation of decisions and follow-up of 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 the initial EDC build on new studies including implementation of standards and facilitating Change Management, issue resolution, impact analysis, proposing solutions and escalation where appropriate
- Execute assigned global library build and maintenance activities
- Perform quality checks to ensure standards implementation aligns with defined specifications
- Document all standards release activities appropriately
Skills
- Doctorate and Clinical Data Standards or EDC Programming experience
- Master's and 3+ years of Clinical Data Standards or EDC Programming experience
- Bachelor's and 5+ years of Clinical Data Standards or EDC Programming experience
- Strong desire and passion to work in Clinical Data Standards development with demonstrated interest in process improvement and operational excellence
- Working knowledge of CDISC standards (CDASH, SDTM, ADaM)
- Experience programming in Medidata Rave EDC
- Experience with at least some 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
- Strong communication and cross-functional collaboration skills
- Detail-oriented with ability to ensure consistency across studies
- Working knowledge of regulatory requirements and industry guidance, including FDA, EMA, ICH and GCP
Benefits
- This position may also be eligible for a discretionary annual bonus.
- This position may also be eligible for discretionary stock-based long-term incentives (eligibility may vary based on role).
- Paid time off.
- Benefits package.
- Company-sponsored medical, dental, vision, and life insurance plans.
Company Overview
Company H1B Sponsorship