Programming Manager, Clinical Programming

Role Overview: This position involves developing and implementing SDTM standards to support clinical study data management, ensuring compliance with industry and regulatory standards. Responsibilities include reviewing data collection tools, guiding SDTM mapping, maintaining data quality, and supporting technology-enabled processes and dashboards. The role emphasizes collaboration with stakeholders, knowledge sharing, and continuous process improvement.

Key Duties

• Implement and support SDTM standards aligned with study and company data collection systems.
• Ensure datasets meet CDISC and regulatory requirements, review data packages for quality.
• Develop quality control processes, metrics, and documentation practices.
• Support the development and review of standard processes and templates.
• Collaborate with Digital Solutions and IT teams on technology strategies and tools.
• Contribute to knowledge sharing, cross-functional collaboration, and process improvements.
• Maintain current knowledge of regulatory guidelines and foster stakeholder relationships.
• Participate in team meetings and represent clinical programming efforts.
  
  

Qualifications & Skills

• Bachelor’s degree in Statistics, Computer Science, or Life Sciences; Master’s preferred.
• 3-5 years of experience in the pharmaceutical industry, with global exposure.
• Proficiency in SAS software and strong understanding of CDISC SDTM data model.
• Analytical, problem-solving, and effective communication skills.
• Ability to work independently, organize tasks, and collaborate effectively in a team.
• Proactive, innovative, goal-oriented, and capable of managing multiple priorities with quality focus.