Senior Associate, Clinical Data Standards Management

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

📋 Description

• Assist in the development and maintenance of global clinical data standards and operational data mappings.

• Implement CDISC standards in the creation of these standards.

• Create and maintain global library objects, which include eCRFs, edit checks, and dynamics.

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

• Contribute to the development of CRF Completion Guidelines.

• Collaborate with Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint, and Veeva Vault for the development, maintenance, and release of the GLV.

• Ensure consistency and adherence to Kite standards across various programs and portfolios.

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

• Prepare documentation, record decisions, and follow up on action items.

• Partner with functional stakeholders to facilitate standards adoption.

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

• Ensure compliance with regulatory requirements, industry standards, GCP/ICH guidelines, and internal procedures.

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

• Execute global library build and maintenance tasks as assigned.

• Conduct quality checks on the implementation of standards.

• Document activities associated with standards release.

⛳️ Requirements

• Doctorate in Clinical Data Standards or EDC Programming experience.

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

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

• Proficient understanding of CDISC standards (CDASH, SDTM, ADaM).

• Experience with programming in Medidata Rave EDC.

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

• Background in global library development.

• Knowledge 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 regulations.

• Proficient knowledge of regulatory requirements and industry guidelines.

• Excellent communication and cross-functional collaboration skills.

• Detail-oriented with the ability to maintain 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.