Associate Manager 1
Role Overview
Provide Level 3 production support for Medidata clinical data management systems in production.
Act as the final escalation point for high-impact or recurring issues from L1 and L2 support teams.
Key Skills for This Role
Full Job Posting
Role overview
Provide Level 3 production support for Medidata clinical data management systems in production.
Act as the final escalation point for high-impact or recurring issues from L1 and L2 support teams.
Core responsibilities
- Manage incidents, problems, change requests, releases, outages, deployments, and configuration changes within defined procedures and SLAs.
- Perform impact assessments, advanced troubleshooting, root cause analysis, and permanent remediation for complex issues.
- Coordinate with interface teams, internal IT teams, vendors, and platform providers on technical resolution and defect remediation.
- Support audits, validation activities, inspection readiness, access reviews, data integrity, backup, and disaster recovery controls.
- Maintain qualification documents, technical documentation, SOPs, work instructions, configuration notes, and knowledge base articles.
- Provide technical guidance to L1 and L2 support teams and contribute to improvements in system stability and support efficiency.
Required qualifications
- Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field.
- Four to eight years of hands-on production support experience for Medidata clinical systems.
- Experience with Medidata Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV.
- Strong understanding of clinical trial data flows, regulated environments, and support models.
- Proven incident, problem, and change management experience with strong analytical, troubleshooting, and communication skills.
Additional experience
- Experience in AMS or Managed Services engagements for global pharmaceutical or biotech clients is advantageous.
- Exposure to clinical data integrations, reporting, reconciliation, UAT defect triage, validation, and audit inspections is advantageous.
- Knowledge of ITIL-based support processes is advantageous.
Compliance environment
- Changes and configurations must comply with FDA, ICH, GCP, and GxP requirements.
- The role supports data integrity, audit trail compliance, security controls, and blinding controls.
Company culture
- Merck Healthcare describes a diverse, inclusive, and collaborative environment focused on science, technology, development, and human progress.
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