Medidata- L3 Support

The role acts as the final technical escalation point for complex incidents impacting live clinical studies and is responsible for ensuring system stability, regulatory compliance, data integrity, and uninterrupted business operations across global clinical trial environments.

The ideal candidate will possess strong knowledge of Medidata applications, clinical trial processes, pharmaceutical regulations, and production support operations within GxP-regulated environments.

Key Responsibilities

L3 Incident Management & Troubleshooting

• Act as the final escalation point for critical and complex production incidents.
• Perform advanced troubleshooting and root cause analysis for application, integration, and configuration issues.
• Coordinate with internal teams and Medidata support for defect resolution and remediation.
• Implement preventive measures to avoid recurring incidents.

Application Support & Administration

• Support and maintain Medidata platforms including:
  • Rave EDC
  • Designer
  • Coder+
  • Rave Safety Gateway
  • TSDV
  • CTMS
  • SSU
  • eTMF
• Support approved configuration changes and minor enhancements.
• Manage application administration and operational activities.

Release & Change Management

• Perform impact analysis for software releases, patches, hotfixes, and upgrades.
• Support deployments across DEV, TEST, and PROD environments.
• Ensure all changes follow approved change management and validation procedures.

Outage & Problem Management

• Manage planned and unplanned outages.
• Coordinate recovery activities and service restoration.
• Support backup verification and disaster recovery readiness activities.

Compliance & Audit Support

• Ensure compliance with:
  • FDA regulations
  • GxP requirements
  • ICH guidelines
  • GCP standards
  • 21 CFR Part 11 requirements
• Support internal and external audits and inspections.
• Maintain audit trails, validation evidence, and qualification documentation.

Documentation Management

• Maintain and update:
  • Functional Requirement Specifications (FRS)
  • Technical Specifications (TS)
  • Technical Risk Assessments (TRA)
  • SOPs
  • Work Instructions
  • Configuration Documentation
  • Knowledge Base Articles
  • Administration Guides

Stakeholder Management

• Collaborate with:
  • Clinical Data Managers
  • Study Designers
  • Integration Teams
  • IT Operations Teams
  • Vendors and Platform Providers
  • Quality and Compliance Teams
• Provide technical guidance and mentoring to L1 and L2 support teams.

Required Skills

• Experience supporting Medidata applications in production environments.
• Strong understanding of clinical trial operations and workflows.
• Experience with Incident, Problem, Change, and Release Management.
• Knowledge of system validation and qualification processes.
• Understanding of audit readiness and regulatory compliance.
• Experience in root cause analysis and troubleshooting.
• Familiarity with database concepts and reporting tools.

Preferred Skills

• Experience with Medidata Rave EDC, CTMS, SSU, and eTMF.
• Knowledge of integrations and interface support.
• Experience supporting global pharmaceutical organizations.
• Exposure to DEV, TEST, and PROD deployment processes.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related discipline.

Preferred Domain Experience

• Pharmaceutical Industry
• Biotechnology
• Clinical Research Organizations (CRO)
• Clinical Trial Operations