Senior Associate, Clinical Data Standards Management (CDSM)

Location: United States – Remote

Salary: $123,930–$160,380 per year, plus potential discretionary bonus and stock-based long-term incentives.

Company

Biopharmaceutical organization developing personalized CAR T-cell and other engineered cell therapies for cancer treatment.

What you will do

• Develop, maintain, and implement global clinical data standards and operational data mappings across clinical programs.
• Apply CDISC standards, including CDASH and SDTM controlled terminology, to standards development.
• Build and maintain global library objects such as eCRFs, edit checks, and dynamics, and support Global Library Volume releases.
• Support initial EDC builds, standards implementation, change management, issue resolution, impact analysis, and escalation for new studies.
• Perform quality checks and document standards release activities to ensure alignment with specifications and regulatory requirements.
• Collaborate with Data Management, Clinical Programming, Biostatistics, Clinical Operations, and governance committees.

Requirements

• Doctorate plus clinical data standards or EDC programming experience; or a master’s degree with 3+ years of relevant experience; or a bachelor’s degree with 5+ years of relevant experience.
• Working knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
• Experience programming in Medidata Rave EDC and understanding of clinical trial data collection and CRF design.
• Knowledge of clinical data management processes, including query management, site concerns, and data collection standards.
• Familiarity with FDA, EMA, ICH, GCP, and other applicable regulatory requirements.
• Strong communication, cross-functional collaboration, attention to detail, and consistency-management skills.

Nice to have

• Experience with Medidata Rave modules such as Rave Coder, Targeted SDV, ePRO, Lab Admin, Rave Safety Gateway, Core Configuration, and IRT Integrations.
• Experience with global library development and process improvement initiatives.

Culture & Benefits

• Remote work arrangement for the United States.
• Medical, dental, vision, and life insurance plans.
• Paid time off.
• Potential discretionary annual bonus and stock-based long-term incentives, subject to eligibility.
• Inclusive work environment focused on employee development, empowerment, and diverse perspectives.