Clinical Data Associate II
Company: Precision Medicine Group
Location: Bangalore, Karnataka, India
Employment Type: Full-time
Function: Clinical Data Management / Clinical Research
Job Summary
The Clinical Data Associate II provides clinical data management support across the complete clinical trial lifecycle, from study start-up through post-database lock activities.
The role involves supporting Lead Data Managers, performing clinical database activities, data review, query management, documentation, quality control, and coordination with internal teams, sponsors, and external vendors to ensure accurate and compliant clinical trial data management.
Key Responsibilities
Clinical Data Management Support
Support Lead Data Managers as a backup and team member to ensure timely completion of clinical data management activities.
Perform clinical data management tasks throughout the study lifecycle, including:
Study start-up activities
Database development
Data review
Database lock support
Post-lock activities
Follow:
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Regulatory requirements
Study-specific plans and guidelines
Clinical Database Development & Testing
Assist in building and maintaining clinical trial databases.
Develop Clinical Research Form (CRF) specifications based on study protocols.
Coordinate review and feedback from clinical study stakeholders.
Conduct:
User Acceptance Testing (UAT)
Database quality checks
Documentation review
Maintain controlled documentation related to database builds and updates.
Data Review & Query Management
Review clinical trial data according to Data Management Plans.
Perform:
Data validation
Query generation and management
Line listing reviews
Data quality checks
Support medical coding activities to ensure consistency and accuracy of medical terminology.
Assist with:
SAE/AE reconciliation
Data discrepancy resolution
Clinical data cleaning activities
Clinical Documentation & Reporting
Create, update, maintain, and version-control clinical data management documents.
Prepare patient-level and study-level status reports and metrics.
Support review of:
Protocols
Statistical Analysis Plans (SAPs)
Clinical Study Reports (CSRs)
Assist in development and maintenance of:
SOPs
Process documentation
Data management workflows
Stakeholder & Vendor Coordination
Communicate with:
Clinical study sponsors
Project teams
External data vendors
EDC system vendors
Coordinate data-related deliverables and timelines.
Support issue identification, troubleshooting, and resolution based on:
Project metrics
Audit findings
Team feedback
Technical & Training Support
Train clinical research personnel on:
Study-specific CRFs
Electronic Data Capture (EDC) systems
Project-related processes
Conduct software demonstrations and training sessions when required.
Assist with SAS programming activities and quality control of SAS programs used in Data Management.
Required Experience
2–4 years of experience preferred in Clinical Data Management, Clinical Research, or Healthcare Data Operations.
Experience supporting clinical trials and working with clinical databases.
Experience with:
EDC systems
CRF design
Data review and query management
Clinical trial documentation
Required Skills & Competencies
Strong understanding of clinical data management processes.
Ability to manage multiple clinical research activities.
Good knowledge of:
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Excellent organizational and communication skills.
Strong attention to detail and commitment to data quality.
Ability to communicate professionally in English (written and verbal).
Ability to collaborate effectively with cross-functional teams.
Educational Qualification
Minimum Qualification:
Bachelor’s degree or equivalent combination of education and relevant experience.
Preferred Background:
Clinical Research
Life Sciences
Healthcare
Pharmacy
Biotechnology
Scientific disciplines
Experience Level
Preferred Experience: 2–4 years in:
Clinical Data Management
Clinical Data Associate Role
Clinical Research Operations
EDC Database Management
Pharmaceutical / CRO Clinical Trials
Suitable Profiles:
Clinical Data Associate II
Clinical Data Coordinator
Clinical Data Management Associate
Clinical Research Data Specialist
Junior Clinical Data Manager
Salary Package (Market Estimate)
Estimated CTC: ₹6–12 LPA (based on Indian Clinical Data Management/CRO market standards, experience level, technical skills, and company benchmarks. Official JD does not specify salary.)
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