Responsibilities
Lead clinical data integration and GxP compliant clinical system implementation projects, ensuring on-time, high-quality, and compliant delivery.
Manage project planning, tracking, risk mitigation, reporting, and stakeholder communication.
Ensure adherence to ICH-GCP, GxP, and 21 CFR Part 11 compliance across systems and processes.
Collaborate with clinical data management, EDC experts, data engineers, QA/CSV teams, and client SMEs.
Oversee data mapping, transformation logic, validation, and testing for project workflows.
Review and optimize end-to-end clinical data workflows using automation tools.
Support change management, documentation, training, and audit readiness.

Qualifications
PMP certification (mandatory).
5+ years of IT Project Management experience; exposure to digital transformation preferred.
Hands-on experience managing clinical trial data workflows and clinical data management projects.
Solid understanding of ICH-GCP, GxP, and 21 CFR Part 11 compliance requirements.
Experience with clinical data automation tools and EDC systems.

Regards,

📌 Lead Pune
🏢 Axtria
📍 Pune