Ready to explore, break barriers, and discover more? We know you’ve got big plans – 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.
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.
Ensure data quality, system integrity, and compliance with industry standards such as FDA, ICH, and GCP.
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.
Develop, maintain, and update documentation, including configuration specifications, process flows, and user guides.
Stay current with system upgrades, Medidata platform releases, and industry trends to recommend process or technology improvements.
Outage Management
Support and manage planned and unplanned outages, including communication, troubleshooting, and service restoration.
Release and Change Management
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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
Your Role:
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.
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.
What we offer: 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!
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