<p style="margin: 0cm 0cm 0cm 108pt; background-color: white; font-size: 11pt; font-family: Calibri, sans-serif;"><span style="font-size: 10.0pt; font-family: Verdana, sans-serif; color: black; background-color: white;">Work Your Magic with us! </span></p><p style="margin: 0cm 0cm 0cm 108pt; background-color: white; font-size: 11pt; font-family: Calibri, sans-serif;"> </p><p style="margin: 0cm 0cm 0cm 108pt; background-color: white; font-size: 11pt; font-family: Calibri, sans-serif;"><span style="font-size: 10.0pt; font-family: Verdana, sans-serif; color: black; background-color: white;">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.</span></p><br><p style="margin:0.0in 0.0in 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Who you are:</strong></span></p><ul style="margin-bottom:0.0in;margin-top:0.0px"><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Configure, customize, and maintain Medidata CTMS, SSU, and eTMF systems to support clinical trial planning, execution, and oversight.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Partner with cross-functional stakeholders to gather business requirements and implement system enhancements or workflow improvements.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Ensure data quality, system integrity, and compliance with industry standards such as FDA, ICH, and GCP.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Provide end-user training, guidance, and support to facilitate effective system usage and adherence to best practices.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Troubleshoot and resolve system issues by coordinating with internal IT teams and external vendors as needed.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Develop, maintain, and update documentation, including configuration specifications, process flows, and user guides.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Stay current with system upgrades, Medidata platform releases, and industry trends to recommend process or technology improvements.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Outage Management</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Support and manage planned and unplanned outages, including communication, troubleshooting, and service restoration. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Release and Change Management</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Manage all aspects of release and change activities, including planning, documentation updates, deployment, and postimplementation review. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>L3 Incident Management and Troubleshooting</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Provide Level3 support for complex incidents, perform advanced troubleshooting, and timely resolution. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Interface Team Coordination</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Collaborate with interface/integration teams to provide required technical details, troubleshooting assistance, and impact analysis. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Problem Management</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Conduct problem investigations, identify root causes, recommend corrective actions, and support prevention of recurring issues. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Audit Support</strong> </span></li></ul><p style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;margin-left:0.0px;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p><p style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;margin-left:0.0px;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Your Role:</span></p><p style="margin-top:0.0in;margin-right:0.0in;margin-bottom:0.0in;margin-left:0.0px;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p><ul style="margin-bottom:0.0in;margin-top:0.0px"><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Provide required evidence, documentation, and support during internal and external audits. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Qualification Documentation Updates</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Update and maintain operational phase qualification documents, including TS, TRA, CS, FRS, Admin Guides, and related artifacts. </span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif"><strong>Review of Data Integrity, Backup, and Disaster Recovery (DR)</strong> </span><br><span style="font-family:verdana, geneva, sans-serif">Perform periodic reviews of data integrity controls, backup processes, and DR readiness for compliance and operational continuity. </span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Act as the final escalation point for high-impact or recurring issues from L1/L2 support teams.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Perform deep root cause analysis (RCA) and implement permanent fixes or preventive controls.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Support approved configuration changes and minor enhancements in line with change management processes.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Manage and resolve incidents, problems, and change requests within defined SLAs.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Coordinate with internal IT teams, vendors, and platform providers for issue resolution and defect remediation.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Support production deployments across DEV, TEST, and PROD environments following validated procedures.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Perform impact assessments for platform releases, patches, and hotfixes affecting live studies.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Ensure all changes and configurations comply with FDA, ICH, GCP, and GxP requirements.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Support validation activities, audit readiness, inspection support, and periodic access reviews.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Ensure data integrity, audit trail compliance, and adherence to security and blinding controls.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Create and maintain technical documentation, configuration notes, SOPs, work instructions, and knowledge base articles.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Provide technical guidance and mentoring to L1/L2 support teams.</span></li><li style="line-height:normal;margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Contribute to continuous improvement initiatives to enhance system stability and support efficiency.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related discipline.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">3 to 8 years of experience in configuration and administration of Medidata CTMS, SSU, and eTMF systems.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Strong understanding of clinical trial operations and applicable regulatory frameworks (FDA, ICH, GCP).</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Proficiency in system configuration, data management, and issue resolution.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Excellent analytical, problem-solving, and communication skills.</span></li><li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Ability to work effectively in a dynamic, cross-functional environment, managing multiple priorities simultaneously.</span></li><li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Experience with additional clinical trial management or electronic data capture (EDC) systems.</span></li><li style="margin:0.0in 0.0in 8.0pt 0.0px;line-height:115%;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Knowledge of database concepts, analytics, and reporting tools.</span></li></ul><br><p style="margin: 0cm 0cm 0cm 144pt; font-size: 11pt; font-family: Calibri, sans-serif;"><strong><span style="font-size: 10.0pt; font-family: Verdana, sans-serif; color: #32363a; background-color: white;">What we offer:<span class="xcontentpasted1"> </span></span></strong><span style="font-size: 10.0pt; font-family: Verdana, sans-serif; color: #32363a; background-color: white;">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!</span></p><p style="margin: 0cm 0cm 0cm 180pt; font-size: 11pt; font-family: Calibri, sans-serif;"><span style="font-size: 10.0pt; font-family: Verdana, sans-serif; color: #32363a;">Apply now and become a part of our diverse team!</span></p>
Originally posted by EMD Group. View original posting
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