Job Title: Clinical Data Manager

Experience: 2-3 Years
Location:
- Ahmedabad, WFO.
Employment Type: Full time

Job Summary

Key Responsibilities
- Manage end-to-end clinical data management activities for assigned clinical studies in accordance with project timelines.
- Review study protocols and contribute to the design and review of electronic Case Report Forms (eCRFs), edit checks, and clinical databases.
- Perform data validation, discrepancy management, and query generation/resolution to ensure data quality, consistency, and completeness.
- Develop and execute data cleaning strategies, including routine data review and reconciliation activities.
- Review clinical trial data for accuracy, integrity, and compliance with study protocols, SOPs, client requirements, and regulatory guidelines.
- Coordinate database User Acceptance Testing (UAT), database updates, and database lock activities.
- Generate data listings, reports, metrics, and study status summaries for internal and external stakeholders.
- Collaborate with Clinical Operations, Biostatistics, Medical Writing,



Medical Monitoring, and external vendors to resolve data-related issues.
- Review and maintain Data Management Plans (DMPs), Data Validation Plans (DVPs), CRF Completion Guidelines, and other study documentation.
- Support medical coding activities using MedDRA and WHO Drug dictionaries, where applicable.
- Ensure compliance with ICH-GCP, CDISC standards, SOPs, and applicable regulatory requirements.
- Participate in audit and inspection readiness activities and address data management findings.
- Prioritize workload effectively to meet project milestones and deliverables.
- Mentor or provide guidance to junior Clinical Data Management associates, as required.

Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline.
- 2-3 years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environ

📌 Clinical Data Manager (Ahmedabad)
🏢 GSC Technologies
📍 Ahmedabad