IT Configuration Specialists - Medidata EDC

Role overview

IT Configuration Specialists - Medidata EDC at Merck

Responsibilities

• Work Your Magic with us!
• Support and manage planned and unplanned outages, including communication, troubleshooting, and service restoration.
• Provide Level3 support for complex incidents, perform advanced troubleshooting, and timely resolution.
• Collaborate with interface/integration teams to provide required technical details, troubleshooting assistance, and impact analysis.
• Conduct problem investigations, identify root causes, recommend corrective actions, and support prevention of recurring issues.
• Provide required evidence, documentation, and support during internal and external audits.
• Review of Data Integrity, Backup, and Disaster Recovery (DR) .
• 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.

Employment details

• Location: Bangalore [Karnataka] [India]

Benefits

• 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.
• We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
• We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.
• We are committed to creating access and opportunities for all to develop and grow at your own pace.
• Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
• Apply now and become a part of our diverse team!

Additional role details

• Ready to explore, break barriers, and discover more?
• We know you’ve got big plans – so do we!
• 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.
• Who you are.
• 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 .
• 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 .
• Interface Team Coordination .
• Problem Management .
• Audit Support .
• Qualification Documentation Updates .
• Update and maintain operational phase qualification documents, including TS, TRA, CS, FRS, Admin Guides, and related artifacts.
• 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.
• 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.
• Your Role .
• 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.