Associate Manager EDC

Job Summary

Provide Level 3 production support for Medidata clinical data management systems like Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV, addressing complex configuration, functional, and data-related issues.

Responsibilities

• Impact and Risk Assessment for Medidata Releases and Configuration Changes.
• Outage Management. Support and manage planned and unplanned outages, including communication, troubleshooting, and service restoration.
• Release and Change Management. Manage all aspects of release and change activities, including planning, documentation updates, deployment, and postimplementation review.
• L3 Incident Management and Troubleshooting. Provide Level3 support for complex incidents, perform advanced troubleshooting, and timely resolution.
• Interface Team Coordination. Collaborate with interface/integration teams to provide required technical details, troubleshooting assistance, and impact analysis.
• Problem Management. Conduct problem investigations, identify root causes, recommend corrective actions, and support prevention of recurring issues.
• Audit Support. Provide required evidence, documentation, and support during internal and external audits.
• Qualification Documentation Updates. Update and maintain operational phase qualification documents, including TS, TRA, CS, FRS, Admin Guides, and related artifacts.
• Review of Data Integrity, Backup, and Disaster Recovery (DR). Perform periodic reviews of data integrity controls, backup processes, and DR readiness for compliance and operational continuity.
• Act as the final escalation point for high-impact or recurring issues from L1/L2 support teams. Perform deep root cause analysis (RCA) and implement permanent fixes or preventive controls.
• Support approved configuration changes and minor enhancements in line with change management processes.
• Manage and resolve incidents, problems, and change requests within defined SLAs. Coordinate with internal IT teams, vendors, and platform providers for issue resolution and defect remediation.
• Support production deployments across DEV, TEST, and PROD environments following validated procedures.
• Perform impact assessments for platform releases, patches, and hotfixes affecting live studies.
• Ensure all changes and configurations comply with FDA, ICH, GCP, and GxP requirements.
• Support validation activities, audit readiness, inspection support, and periodic access reviews.
• Ensure data integrity, audit trail compliance, and adherence to security and blinding controls.
• Create and maintain technical documentation, configuration notes, SOPs, work instructions, and knowledge base articles.
• Provide technical guidance and mentoring to L1/L2 support teams.
• Contribute to continuous improvement initiatives to enhance system stability and support efficiency.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related field.
• 4 to 8 years of hands-on experience providing L3 support for Medidata clinical systems in production, specifically Medidata Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV.
• Strong understanding of clinical trial data flows, regulated environments, and support models.
• Proven experience in incident, problem, and change management.
• Excellent analytical, troubleshooting, and communication skills.
• Experience working in AMS / Managed Services engagements for global pharmaceutical or biotech clients.
• Exposure to clinical data integrations, reporting, and reconciliation.
• Experience supporting UAT defect triage, validation, and audit inspections.
• Knowledge of ITIL-based support processes.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.