Clinical Data Analyst – CPS Data Management

BioTechTrek; India; On-site; INR 600,000 - 1,200,000; Full time

Job summary

BioTechTrek is seeking a Clinical Data Analyst to review clinical trial data, manage data queries, and ensure data quality. The role involves following Data Management Plans, Edit Check Specifications, and Data Review Guidelines, with responsibilities spanning reconciliation and database testing.

Key tasks include generating diagnostics, supporting EMR/ETMF documentation, and assisting in project closure activities. Familiarity with SAS reports and eCRF review is desirable.

Qualifications

• Experience in clinical data management and data review workflows.
• Familiarity with eCRF/CRF processes and data reconciliation.
• Understanding of GCP and eTMF practices is a plus.

Responsibilities

• Perform clinical trial data review and query management activities.
• Review data according to Data Management Plans and Edit Check Specifications.
• Generate, resolve and track clinical data queries.
• Support database setup, maintenance and project closure activities.
• Create dummy data for testing database edit checks.

Skills

Clinical Data Management

Data review

Query management

sCRF/eCRF review

SAS reports

GCP

Data reconciliation

Database testing

Tools

SAS

Job description

Clinical Data Analyst – CPS Data Management

Perform clinical trial data review and query management activities.Review data according to Data Management Plans, Edit Check Specifications and Data Review Guidelines.Identify erroneous, incomplete or missing clinical data.Generate, resolve and track clinical data queries.Perform reconciliation activities.Generate diagnostics, special listings and reconciliation discrepancy listings.Support clinical database setup, maintenance and project closure activities.Assist in creating and reviewing Edit Check Specifications.Create dummy data for testing database edit checks.

Required Skills

Clinical Data Management (CDM)Clinical trial data reviewQuery generation and resolutionData reconciliationEdit checkseCRF/CRF reviewDatabase testingData Management PlanseTMF documentationMedical terminologyGCPDrug developmentDatabase lock activitiesSAS reports/data listings