NC
ETMF IT SME
NR Consulting - India
🇮🇳 India
On-site
1 week ago
- Change Management
- GxP
- Veeva Vault
1 week ago
Location: Bangalore, Chennai, Mumbai
Exp: 3-6 Yrs
Job Description:
• Provide L2/L3 support for eTMF applications and related clinical systems.
• Manage incident, problem, and change management activities.
• Support user access management, configuration, and system monitoring.
• Coordinate with business users, vendors, and global stakeholders for issue resolution and enhancements.
• Ensure compliance with GxP, SOPs, and audit requirements.
• Support release activities, validation, and system upgrades.
• Prepare operational reports, KPIs, and documentation. Participate in process improvements and knowledge management activities.
Required Skills
• 4–6 years of experience in eTMF application support or clinical IT support.
• Hands-on experience with eTMF platforms such as Veeva Vault eTMF, OpenText, or similar systems.
• Good understanding of clinical trial processes and TMF management.
• Experience in ITSM tools and support processes (Incident, Change, Problem Management).
• Knowledge of GxP compliance and Life Sciences domain.
• Strong communication and stakeholder management skills.
ETMF IT SME · NR Consulting - India