Associate Manager 1

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. Impact and Risk Assessment for Medidata Releases and Configuration Changes. Carry out approved configuration tasks in accordance with defined procedures and change controls.

Responsibilities

• 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 Level 3 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. 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

• 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.

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