SME-Clinical Data Management

Key Responsibilities

1. Carry out CDM activities such as data cleaning, manual and system checks, query management, and issue resolution.
2. Oversee study trackers, discrepancy review, database lock-related activities, and supporting documentation.
3. Provide hands-on clinical study setup and support multiple clinical trials across therapeutic areas.
4. Deliver assigned activities on time, aligned with client SLAs and established quality standards.
5. Recognize opportunities for process improvement and coordinate corresponding action plans with the Team Lead.
6. Produce and maintain audit-ready documentation in line with quality and security requirements.
7. Handle third-party data including Lab, PK and Imaging datasets.
8. Collaborate with clients and internal stakeholders to address issues and support seamless study delivery.

Required Skills

• Core Clinical Data Management (CDM)
• Study Setup and Database Lock
• Medidata Rave / Veeva EDC
• Data Cleaning, Validation and Query Management
• Third-Party Data Handling (Lab, PK, Imaging)
• Spotfire Reporting
• Client Communication and SLA Management