Senior Associate Clinical Data Insights Analyst

Jobtailor; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Jobtailor in Bengaluru is seeking an experienced professional to manage user access across clinical data management systems (EDC and eCOA), create, modify, and deactivate user accounts, and perform configuration activities to support study teams.

You will ensure GxP compliance, maintain documentation to SOPs, collaborate with cross-functional and global teams to meet timelines, and drive process improvements with best practices across the organization.

Qualifications

• Bachelor's or Master's degree in Life Sciences, CS, IT, Clinical Information Management, or related field.
• 2-3 years of experience within the pharmaceutical, biotechnology, clinical research, or healthcare industry.
• Experience working with Clinical Data Management systems, user access management, vendor systems, or related platforms.
• Knowledge of clinical trial processes and GxP requirements within drug development.
• Strong understanding of computer systems, applications, and IT processes.
• Excellent written and verbal communication skills in English.

Responsibilities

• Managing site and user access across CDM systems (EDC and eCOA).
• Creating, maintaining, and deactivating user accounts for internal and external stakeholders.
• Performing configuration activities within user management tools and Veeva systems.
• Managing rights, roles, study setup activities, and study closure/decommissioning processes.
• Supporting incident management and resolving user access and system-related queries.
• Ensuring documentation is maintained in accordance with SOPs, GCP, GDP, and GxP requirements.
• Collaborating with cross-functional and global teams to meet project timelines and operational goals.
• Contributing to process improvements and sharing best practices across teams and functions.

Skills

User Access Management

Clinical Data Management

GxP Compliance

Incident Management

Cross-Functional Collaboration

Education

Life Sciences/IT degree

Tools

EDC Platforms

ECOA Platforms

Veeva Systems

Job description

• Managing site and user access across clinical data management systems such as EDC and eCOA platforms.
• Creating, maintaining, and deactivating user accounts for internal and external stakeholders.
• Performing configuration activities within user management tools and Veeva systems.
• Managing rights, roles, study setup activities, and study closure/decommissioning processes.
• Supporting incident management and resolving user access and system-related queries.
• Ensuring documentation is maintained in accordance with company standards, SOPs, GCP, GDP, and GxP requirements.
• Collaborating with cross-functional and global teams to meet project timelines and operational goals.
• Contributing to process improvements and sharing best practices across teams and functions.

Requirements

• Bachelor's or Master's degree in Life Sciences, Computer Science, Information Technology, Clinical Information Management, or a related field.
• 2-3 years of experience within the pharmaceutical, biotechnology, clinical research, or healthcare industry.
• Experience working with Clinical Data Management systems, user access management, vendor systems, or related platforms.
• Knowledge of clinical trial processes and GxP requirements within drug development.
• Strong understanding of computer systems, applications, and IT processes.
• Excellent written and verbal communication skills in English.

Core Competencies

Demonstrates expertise in managing user access across clinical data management systems, ensuring compliance with GxP requirements, and collaborating with cross-functional teams to enhance operational efficiency. Proficient in user management tools and maintaining documentation in accordance with company standards.

Highest-signal resume keywords

• Clinical Data Management
• User Access Management
• GxP Compliance
• Incident Management
• Cross-Functional Collaboration

ATS Optimization Keywords

Hard Skills

• User Account Management
• Configuration Activities
• Study Setup Activities
• Documentation Maintenance
• Clinical Trial Processes

Soft Skills

• Excellent Communication Skills

Industry Keywords

• Pharmaceutical Industry
• Biotechnology
• Clinical Research
• Healthcare

Tools & Technologies

• EDC Platforms
• ECOA Platforms
• Veeva Systems