Clinical Research Associate

Overview

In this remote, senior role you shape and govern clinical data standards within oncology trials in a CRO setting. You will lead the development and implementation of data standards, ensuring regulatory alignment and CDISC compliance, while guiding cross-functional teams and mentoring junior colleagues. You’ll influence governance decisions and drive improvements across complex studies, making an impact on data quality and study success. This position offers strategic impact, mentorship, and the chance to shape standards for global oncology programs.

Responsibilities

• Develop, implement, and maintain data collection standards libraries
• Ensure CDISC, sponsor, and regulatory compliance for data standards
• Act as SME for standards implementation and compliance
• Define data collection strategies and standards for clinical trials
• Identify business challenges and propose innovative solutions
• Drive process, product, and service improvements related to data standards
• Participate in standards governance and contribute to complex topics
• Lead or contribute to departmental and cross-functional initiatives
• Coordinate project teams when leading initiatives or projects
• Develop training materials and reference documentation (e.g., CDASH, Controlled Terminology)
• Monitor regulatory developments and industry trends in standards
• Mentor and provide technical guidance to junior team members
• Build stakeholder alignment by presenting and defending recommendations

Key requirements

• Degree in Life Sciences, Computer Science, or a related field
• Strong expertise in clinical data standards (CDASH, SDTM, Controlled Terminology)
• In-depth understanding of FDA, EMA, and other regulatory expectations
• Hands-on experience with EDC platforms such as Medidata Rave or Veeva Vault
• Proven ability to analyze and resolve complex technical challenges
• Experience leading initiatives, coordinating projects, or mentoring colleagues
• Excellent communication, presentation, and stakeholder management skills
• Ability to influence decisions and align stakeholders on complex topics
• Track record of delivering high-quality outcomes aligned with organizational objectives

• communication
• leadership
• mentoring
• CDASH
• SDTM
• Controlled Terminology

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