Clinical Programming Manager

Role Overview

This position involves developing and supporting SDTM standards for clinical data to ensure compliance with industry and regulatory requirements. It includes reviewing study data, creating quality control processes, and collaborating with digital and IT teams to implement technology solutions. The role also entails contributing to process improvements, maintaining knowledge of regulatory guidelines, and supporting global cross-functional teams.

Key Responsibilities

• Implement and assist in developing SDTM standards aligned with data collection and regulatory needs.
• Ensure datasets meet CDISC standards and review data packages for quality and compliance.
• Create quality control metrics and ensure adherence to SOPs and industry regulations.
• Support the development of process templates and collaborate with IT for technology-enabled solutions.
• Contribute to knowledge sharing, training, and process improvements across teams.
• Maintain up-to-date knowledge of regulatory guidelines and foster stakeholder relationships.
• Participate in team meetings and represent clinical programming initiatives.

Qualifications & Skills

• Bachelor's degree in Statistics, Computer Science, Life Sciences (Master's preferred).
• 3-5 years of experience in the pharmaceutical industry, with global exposure.
• Proficiency in SAS programming and strong knowledge of CDISC SDTM data model.
• Excellent problem-solving, communication, planning, and organizational skills.
• Ability to work independently, manage multiple tasks, and share knowledge effectively.

Additional Expectations

• Lead study teams, act as a role model, mentor new staff, and proactively support departmental initiatives.