Primary Skill
1) Statistical Computing Environment (SCE)
2) Clinical Data Repository (CDR)
3) Clinical data management (CDM)
Key Responsibilities
- Provide L2/L3 support for e-Clinical systems and related applications.
- Manage incidents, service requests, problem, and change management activities.
- Support system configuration, user access management, and application monitoring.
- Coordinate with clinical teams, business users, vendors, and onsite stakeholders for issue resolution and enhancements.
- Ensure compliance with GxP, SOPs, and regulatory requirements.
- Support validation, release management, and system upgrade activities.
- Prepare operational reports, KPIs, and support documentation.
- Participate in process improvement and knowledge management initiatives.
Required Skills
- 4–6 years of experience in e-Clinical application support or Clinical IT support.
- Hands-on experience with Clinical platforms such as CDR, Clinical Data, Clinical analytics.
- Preferred exposure to CTMS, EDC, eTMF, RTSM, or similar systems.
- Good understanding of clinical trial processes and Life Sciences domain.
- Experience in ITSM/support processes including Incident, Change, and Problem Management.
- Knowledge of GxP compliance and validation processes.
- Strong communication and stakeholder management skills.
Qualification
Bachelor's degree in Computer Science, Life Sciences, Pharmacy, or related field.
