PHARMAFull-time
IT Configuration Specialist - Medidata EDC
By Admin · Clinical Data Management
BANGALORE (IN)ONSITEPOSTED: 9/6/2026
PHARMAFull-time
HIRING ORGANIZATIONMERCK KGAAPharmaceuticals and Life Sciences
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Provide Level 3 production support for Medidata clinical data management platforms including Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV.
Resolve complex configuration, functional, data, and production-support issues affecting clinical systems.
Perform impact and risk assessments for Medidata platform releases and configuration changes.
Execute approved configuration activities according to defined procedures and formal change controls.
Manage planned and unplanned outages, including communication, troubleshooting, service restoration, and stakeholder coordination.
Manage release and change activities covering planning, documentation updates, deployment, and post-implementation review.
Provide L3 incident management, advanced troubleshooting, and timely resolution of complex incidents.
Coordinate with interface and integration teams by providing technical details, troubleshooting assistance, and impact analysis.
Conduct problem investigations, identify root causes, recommend corrective actions, and support prevention of recurring issues.
Provide documentation, evidence, and operational support for internal and external audits.
Maintain operational-phase qualification documentation including TS, TRA, CS, FRS, Admin Guides, and related artifacts.
Perform periodic reviews of data-integrity controls, backup processes, and disaster-recovery readiness.
Act as the final escalation point for high-impact or recurring issues escalated from L1/L2 support teams.
Perform deep root-cause analysis and implement permanent fixes or preventive controls.
Support approved configuration changes and minor system enhancements under change-management processes.
Manage 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 using validated procedures.
Perform impact assessments for platform releases, patches, and hotfixes affecting live clinical studies.
Regulatory, Validation & Data Integrity
Ensure Medidata system configurations and changes comply with FDA, ICH, GCP, and GxP requirements.
Support system-validation activities, audit readiness, and inspection support.
Conduct periodic access reviews.
Ensure clinical data integrity, audit-trail compliance, security controls, and appropriate blinding controls.
Support UAT defect triage, validation activities, and audit/inspection requirements.
Documentation & Knowledge Management
Create and maintain technical documentation, configuration notes, SOPs, work instructions, and knowledge-base articles.
Maintain qualification documentation and operational artifacts required for regulated clinical systems.
Provide technical guidance and mentoring to L1/L2 support teams.
Contribute to continuous-improvement initiatives designed to improve system stability and support efficiency.
Required Qualifications & Experience
Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related field.
4-8 years of hands-on L3 production-support experience with Medidata clinical systems.
Specific experience with Medidata Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV.
Strong understanding of clinical-trial data flows, regulated environments, and clinical-system support models.
Proven incident, problem, and change-management experience.
Strong analytical, troubleshooting, and communication skills.
Experience working in AMS/Managed Services engagements for global pharmaceutical or biotechnology clients.
Exposure to clinical-data integrations, reporting, and reconciliation.
Experience supporting UAT defect triage, validation, and audit inspections.
Knowledge of ITIL-based support processes.
Operational & Leadership Impact
Serve as the final technical escalation point for critical or recurring production issues.
Coordinate across IT, integration teams, vendors, and platform providers.
Guide L1/L2 teams through complex technical problems and provide mentoring.
Drive permanent corrective actions and preventive controls rather than only resolving individual incidents.
Contribute to system reliability, compliance, operational continuity, and support-process improvements.
Work Environment & Company Offering
Full-time role based in Bangalore, Karnataka, India.
Merck KGaA emphasizes diversity, inclusion, equal access to opportunities, professional development, and the ability for employees to grow at their own pace.
REQUIRED VERIFIED SKILLS
Medidata Rave EDC
Coder+
Designer
Rave Safety Gateway
TSDV
Level 3 Production Support
Clinical Data Management Systems
Incident Management
Problem Management
Change Management
Release Management
Root Cause Analysis
Clinical Trial Data Flows
Data Integration
Data Reconciliation
UAT Defect Triage
Validation
Audit Support
ITIL
FDA
ICH
GCP
GxP
Data Integrity
Audit Trails
Security Controls
Blinding Controls
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
No salary range is disclosed in the supplied Merck KGaA posting. The position requires 4-8 years of specialized Medidata L3 experience and regulated clinical-system expertise, so compensation would typically be evaluated against experienced clinical IT/application-support market levels. The source does not provide specific salary, bonus, incentive, or benefit amounts, so these should be confirmed through the official recruitment process.
ORGANIZATION CONTEXT & CULTURE
Merck KGaA is actively hiring for this position.
INDUSTRY: Pharmaceuticals and Life Sciences
EXPECTED CAREER ROADMAP
This role offers a specialized career path in clinical IT and electronic clinical data systems, with potential progression toward senior clinical systems specialist, technical lead, Medidata platform lead, clinical systems manager, application support manager, validation/quality leadership, or broader clinical technology management. Deep expertise in Medidata Rave, regulated-system support, ITIL, validation, data integrity, and production operations can also support consulting and managed-services leadership opportunities across pharmaceutical, biotechnology, CRO, and clinical-technology organizations.
APPLICATION ADVISORY
Emphasize hands-on Medidata Rave production-support experience and clearly list Rave EDC, Coder+, Designer, Rave Safety Gateway, and TSDV if you have them. Highlight L3 incident/problem/change management, RCA, release management, DEV/TEST/PROD deployments, validation, UAT defect triage, audit support, FDA/ICH/GCP/GxP compliance, data integrity, and ITIL. Quantify production incidents resolved, SLA performance, system improvements, audit outcomes, and major releases supported. Prepare scenario-based examples covering critical incidents, outages, root-cause analysis, change controls, validation, clinical-data integrations, and escalation management.
RECOMMENDED TRAINING
1/5
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