Associate Manager Medidata EDC

Merck; Bengaluru; On-site; INR 1,200,000 - 2,600,000; Full time

Job summary

Merck in Bengaluru seeks an experienced L3 Medidata support engineer to join our global life sciences team. You will provide Level 3 production support for Medidata Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV, handling complex configuration, data issues, and regulatory-compliant change control.

You will lead outages, coordinate releases, manage incidents and problems, and mentor L1/L2 teams. Strong ITIL knowledge, data integrity focus, and collaboration with QA/audit teams are

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related field.
• 4 to 8 years of hands-on L3 support for Medidata clinical systems in production (Rave EDC, Coder+, Designer, Rave Safety Gateway, TSDV).
• Strong understanding of clinical trial data flows and regulated environments.
• Proven experience in incident, problem, and change management.
• Excellent analytical, troubleshooting, and communication skills.
• Experience in AMS/Managed Services engagements for global pharma/biotech clients.

Responsibilities

• Provide Level 3 production support for Medidata systems (Rave EDC, Coder+, Designer, Rave Safety Gateway, TSDV).
• Assess impact and risk for Medidata releases and configuration changes.
• Perform approved configuration tasks per procedures and change controls.
• Support outages, including communication and service restoration.
• Manage releases and changes: planning, documentation, deployment, post-implementation review.
• Lead L3 incident management and troubleshooting for complex issues.
• Coordinate with interface teams for technical details and impact analysis.
• Conduct root cause investigations and implement preventive controls.
• Support validation activities, audits, and inspection readiness.
• Ensure data integrity, audit trails, and security controls.

Skills

Analytical skills

Communication skills

Troubleshooting

Leadership

Education

Bachelor's degree in Life Sciences/CS/IT

Tools

Medidata Rave EDC

Rave Coder+

Rave Designer

Rave Safety Gateway

TSDV

Job description

Job Summary

Work your magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans-and so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

Responsibilities

• 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.
• 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.