IT Configuration Specialist - Medidata CTMS\\SSU & eTMF

Role overview

IT Configuration Specialist - Medidata CTMS\\SSU & eTMF at Merck

Responsibilities

• Work Your Magic with us!
• Ensure data quality, system integrity, and compliance with industry standards such as FDA, ICH, and GCP.
• Develop, maintain, and update documentation, including configuration specifications, process flows, and user guides.
• Support and manage planned and unplanned outages, including communication, troubleshooting, and service restoration.
• Manage all aspects of release and change activities, including planning, documentation updates, deployment, and postimplementation review.
• 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 periodic reviews of data integrity controls, backup processes, and DR readiness for compliance and operational continuity.
• 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.
• Configure, customize, and maintain Medidata CTMS, SSU, and eTMF systems to support clinical trial planning, execution, and oversight.
• Partner with cross-functional stakeholders to gather business requirements and implement system enhancements or workflow improvements.
• Provide end-user training, guidance, and support to facilitate effective system usage and adherence to best practices.
• Troubleshoot and resolve system issues by coordinating with internal IT teams and external vendors as needed.
• Stay current with system upgrades, Medidata platform releases, and industry trends to recommend process or technology improvements.
• Outage Management .
• Release and Change Management .
• L3 Incident Management and Troubleshooting .
• Interface Team Coordination .
• Problem Management .
• Audit Support .
• Your Role.
• Qualification Documentation Updates .
• Update and maintain operational phase qualification documents, including TS, TRA, CS, FRS, Admin Guides, and related artifacts.
• 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 discipline. 3 to 8 years of experience in configuration and administration of Medidata CTMS, SSU, and eTMF systems.
• Strong understanding of clinical trial operations and applicable regulatory frameworks (FDA, ICH, GCP).
• Proficiency in system configuration, data management, and issue resolution.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work effectively in a dynamic, cross-functional environment, managing multiple priorities simultaneously.
• Experience with additional clinical trial management or electronic data capture (EDC) systems.
• Knowledge of database concepts, analytics, and reporting tools.