Clinical Specialist

NR Consulting · Bengaluru, India

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.