Senior Associate, Clinical Data Standards Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the creation and upkeep of global clinical data standards and operational data mappings.

• Implement CDISC standards, including CDASH and SDTM controlled terminology, in the development of standards.

• Create and maintain global library objects, such as eCRFs, edit checks, and dynamics.

• Aid in the regular updates of the Global Library Volume (GLV).

• Contribute to the creation of CRF Completion Guidelines.

• Collaborate with Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, and Veeva Vault to facilitate GLV development, maintenance, and distribution.

• Ensure consistency and compliance with Kite standards across various programs and portfolios.

• Support the activities of the Standards Core Committee and Standards Governance Committee.

• Prepare documentation, record decisions, and track action items.

• Collaborate with functional stakeholders to promote standards adoption.

• Identify and propose process enhancements and support initiatives related to standards.

• Guarantee adherence to regulatory requirements, industry standards, GCP/ICH guidelines, and internal procedures.

• Provide study support during initial EDC builds, covering standards implementation, change management, issue resolution, impact analysis, solution proposals, and escalation.

• Execute the assigned activities for global library build and maintenance.

• Conduct quality checks to ensure that standards implementation meets defined specifications.

• Document activities related to standards release.

⛳️ Requirements

• Doctorate in Clinical Data Standards or EDC Programming experience.

• OR Master’s degree with 3+ years of experience in Clinical Data Standards or EDC Programming.

• OR Bachelor’s degree with 5+ years of experience in Clinical Data Standards or EDC Programming.

• Strong enthusiasm and commitment to working in the development of Clinical Data Standards.

• Proven interest in process improvement and operational excellence.

• Working knowledge of CDISC standards (CDASH, SDTM, ADaM).

• Experience with programming in Medidata Rave EDC.

• Familiarity with Medidata Rave modules, including Rave Coder, Targeted SDV (TSDV), ePRO, Lab Admin, Rave Safety Gateway (RSG), Core Configuration, and IRT Integrations.

• Experience in the development of global libraries.

• Understanding of clinical trial data collection and CRF design.

• Knowledge of clinical data management processes, such as query management, site concerns, and data collection standards.

• Familiarity with FDA, EMA, ICH, and GCP requirements.

• Working knowledge of regulatory requirements and industry guidance.

• Excellent communication and cross-functional collaboration abilities.

• Detail-oriented with a strong 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.

• Comprehensive benefits package.