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Clinical Specialist
Job description
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.
Required skills
validation
pharmacy
kpis
gxp
it support
change management
computer science
incident management
regulatory requirements
itsm
problem management
sops
life sciences
release management
ctms
cdm
knowledge management
system upgrades
cdr
edc
system configuration
user access management
clinical data management
operational reports
application monitoring
etmf
service request management
sce
rtsm
clinical analytics
clinical trial processes
statistical computing environment
clinical data repository
e-clinical systems
clinical it support
clinical platforms
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Company information
- Company
- NR Consulting
- Location
-
India, Karnataka, Bangalore
India - Posted
- 2 weeks ago
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