Required Experience:

Minimum 3 years of hands-on Clinical Data Management (CDM) experience with complete study lifecycle management.

Solid experience in end-to-end clinical trial data management activities.

Key Responsibilities & Skills:

Study Start-Up

CRF/eCRF review and development.

Data Management Plan (DMP) preparation.

Edit Check Specification writing and review.

Validation/User Acceptance Testing (UAT) of clinical databases.

Database build review and study setup activities.

Study Conduct

Ongoing data review and cleaning.

Query generation, management, and resolution.

External data reconciliation (e.g., Laboratory, SAE, ECG, PK data).

Study metrics and status reporting.

Data quality management and issue tracking.

Study closeout

Database Lock Activities

Database Freeze and Snapshot activities.

Pre-lock data review and reconciliation.

Database Lock (DB Lock) execution.

Study close-out documentation and final data delivery.

Preferred Systems/Tools

Medidata Rave, Oracle Clinical/InForm, Veeva CDMS, or similar EDC platforms.

Proficiency in Microsoft Excel and clinical data standards.

📌 Clinical Data Coordinator (Hyderabad)
🏢 Iqvia
📍 Hyderabad