Now hiring

IT Configuration Specialist - Medidata EDC (Bangalore, Karnataka, IN, 560100) @ SUSONITY

Bangalore, Karnataka, IN, 560100OnsiteFull-time
Apply with ResuMinder

Opens on the employer's site

About this role

<p style="margin:0.0cm 0.0cm 0.0cm 108.0pt;background-color:white;font-size:11.0pt;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:0.0cm 0.0cm 0.0cm 108.0pt;background-color:white;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 0.0cm 108.0pt;background-color:white;font-size:11.0pt;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> <p style="margin:0.0cm 0.0cm 0.0cm 36.0pt;font-size:11.0pt;font-family:Calibri, sans-serif"> </p><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="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 Level 3 production support for Medidata clinical data management systems like <strong>Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV,</strong> addressing complex configuration, functional, and data-related issues.</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">Impact and Risk Assessment for Medidata Releases and Configuration Changes</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">Carry out approved configuration tasks in accordance with defined procedures and change controls.</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><br><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 8.0pt 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> </ul> <p style="line-height:normal;margin:0.0in 0.0in 8.0pt;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Your Role:</span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <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">Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field.</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">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.</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">Strong understanding of clinical trial data flows, regulated environments, and support models.</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">Proven experience in incident, problem, and change management.</span></li> <li style="line-height:normal;margin:0.0in 0.0in 8.0pt 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Excellent analytical, troubleshooting, and communication skills.</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">Experience working in AMS / Managed Services engagements for global pharmaceutical or biotech clients.</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">Exposure to clinical data integrations, reporting, and reconciliation.</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">Experience supporting UAT defect triage, validation, and audit inspections.</span></li> <li style="line-height:normal;margin:0.0in 0.0in 8.0pt 0.0px;font-size:12.0pt;font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Knowledge of ITIL-based support processes.</span></li> </ul><p style="margin:0.0cm 0.0cm 0.0cm 144.0pt;font-size:11.0pt;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:0.0cm 0.0cm 0.0cm 180.0pt;font-size:11.0pt;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> <p style="margin:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif"> </p>

Ready to apply?

Install the ResuMinder extension and we'll auto-fill the application in seconds — no rewriting.

See how your CV scores