Clinical Data Associate II
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Role Summary
The Clinical Data Associate II is responsible for supporting clinical data management activities throughout the clinical trial lifecycle, from study start-up through database lock and study closeout. The role involves database development, data review, query management, medical coding, vendor coordination, reporting, and quality control activities to ensure high-quality, accurate, and regulatory-compliant clinical trial data.
This position works closely with Lead Data Managers, sponsors, clinical operations teams, vendors, and other stakeholders to support the successful execution of clinical studies while maintaining adherence to SOPs, regulatory requirements, and data management standards.
Key Responsibilities
Clinical Data Management Operations
Support all phases of the clinical data management lifecycle:
Study Start-Up
Database Development
Data Cleaning
Database Lock
Post-Lock Activities
Act as a backup and support resource for the Lead Data Manager.
Ensure timely completion of assigned data management deliverables.
Follow study-specific plans, SOPs, and regulatory guidelines.
Case Report Form (CRF) Development & Management
Develop and review CRF specifications based on study protocols.
Coordinate CRF review cycles with:
Sponsors
Clinical Teams
Biostatistics
Medical Teams
Ensure CRFs accurately capture protocol-required data.
Support implementation of CRF updates and revisions.
Database Development & User Acceptance Testing (UAT)
Assist in building and configuring clinical databases.
Conduct:
Database User Acceptance Testing (UAT)
Functional Testing
Quality Verification Activities
Maintain controlled documentation for database builds and testing.
Ensure database quality and compliance before deployment.
Data Review & Query Management
Review clinical trial data according to the Data Management Plan.
Identify and resolve:
Data Discrepancies
Missing Information
Protocol Deviations
Data Inconsistencies
Generate and manage data queries.
Follow up with investigative sites and stakeholders to resolve issues.
Perform line listing reviews and data validation activities.
Edit Check Development & Validation
Assist in defining and documenting requirements for:
Automated Edit Checks
Manual Data Reviews
Data Validation Rules
Support implementation and testing of edit checks.
Ensure edit checks effectively identify data quality issues.
Medical Coding & Data Standardization
Perform medical coding activities for:
Adverse Events (AEs)
Medical History
Concomitant Medications
Other Medical Terms
Ensure coding consistency and medical logic.
Maintain alignment with approved coding dictionaries and standards.
Support coding quality reviews and reconciliation activities.
SAE/AE Reconciliation
Assist with:
Serious Adverse Event (SAE) Reconciliation
Adverse Event (AE) Reconciliation
Collaborate with:
Pharmacovigilance Teams
Clinical Operations
Sponsors
Ensure consistency across safety and clinical databases.
Vendor & Stakeholder Coordination
Liaise with:
External Data Vendors
EDC Vendors
Clinical Trial Stakeholders
Track data-related deliverables and timelines.
Support vendor issue resolution and project coordination activities.
Ensure timely receipt and integration of external data.
Reporting & Metrics Management
Generate and maintain:
Patient Status Reports
Study Status Reports
Data Management Metrics
Operational Dashboards
Monitor study progress and data quality indicators.
Support management reporting and decision-making activities.
Documentation & Quality Management
Create, maintain, and version-control:
Data Management Plans
Data Review Documentation
Validation Documentation
Database Build Documentation
Study-Specific Data Management Files
Ensure documentation remains audit-ready and compliant.
Support quality assurance activities and inspections.
Training & User Support
Train study personnel on:
CRFs
Electronic Data Capture (EDC) Systems
Study-Specific Processes
Provide user support for data management systems and processes.
Participate in departmental and project-specific training initiatives.
SAS Programming & Technical Support
Assist with:
SAS Programming Activities
Program Validation
Quality Control of SAS Outputs
Support data extraction and reporting activities.
Collaborate with programmers and biostatistics teams as needed.
Protocol & Study Documentation Review
Assist in reviewing:
Clinical Study Protocols
Statistical Analysis Plans (SAPs)
Clinical Study Reports (CSRs)
Provide data management feedback and recommendations.
Ensure data collection and reporting requirements are clearly defined.
Process Improvement & SOP Development
Participate in development and maintenance of:
Standard Operating Procedures (SOPs)
Work Instructions
Process Documentation
Support continuous improvement initiatives within the Data Management function.
Identify opportunities to improve efficiency and quality.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Biotechnology
Pharmacy
Nursing
Healthcare Sciences
Statistics
Computer Science
Related Discipline
OR
Equivalent combination of education and relevant experience.
Experience
2–4 years of experience in:
Clinical Data Management
Clinical Research
CRO Environment
Pharmaceutical Industry
Experience supporting clinical trials across various study phases.
Exposure to electronic data capture (EDC) systems preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
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Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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