CTMS Business expert

Role Summary

Looking for an experienced CTMS Business Expert to support and manage Clinical Trial Management System (CTMS) operations within the Life Sciences domain. The candidate will act as a functional SME, supporting business users, system operations, and process improvements for global clinical studies.

Key Responsibilities

• Provide functional support for CTMS applications and clinical operations.
• Work closely with clinical teams, business users, and IT teams for issue resolution and enhancements.
• Support study setup, user access management, data review, and system administration activities.
• Analyze business requirements and support process improvement initiatives.
• Coordinate incident, problem, and change management activities.
• Ensure compliance with GxP, SOPs, and clinical regulatory standards.
• Support UAT, validation, release management, and reporting activities.
• Prepare operational documentation, KPIs, and training materials.

Required Skills

• 4–6 years of experience in CTMS support or Clinical Operations.
• Hands-on experience with CTMS platforms such as Veeva CTMS, Medidata, Oracle Siebel CTMS, or similar systems.
• Good understanding of clinical trial lifecycle and clinical operations processes.
• Experience in stakeholder coordination and offshore support model.
• Knowledge of GxP compliance and validation processes.
• Strong analytical, communication, and problem-solving skills.

Qualification

Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or related field.