Clinical Data Management Associate
ClinoGenesis Research Institute
Hyderabad, Telangana, India0–2 yrs6m agovia LinkedIn
About the Role
The Clinical Data Management Associate supports the collection, review, cleaning, validation, and management of clinical trial data to ensure it is accurate, complete, consistent, and compliant with applicable clinical research standards.
Key Responsibilities
- Support clinical data management activities for clinical trials.
- Perform data review, validation, and discrepancy identification.
- Assist with EDC (Electronic Data Capture) systems and clinical databases.
- Review eCRFs/CRFs for completeness, consistency, and accuracy.
- Generate and resolve data queries in coordination with clinical sites and study teams.
- Assist with data cleaning, reconciliation, and quality checks.
- Support database setup, testing, and data validation activities.
- Perform reconciliation of clinical data with laboratory, safety, and other external data sources.
- Maintain accurate documentation and study-related records.
- Follow SOPs, GCP, CDISC, and regulatory requirements.
- Collaborate with Clinical Operations, Biostatistics, Medical Coding, Pharmacovigilance, and other project teams.
- Support database lock and study close-out activities.
Qualifications
- B.Pharm / M.Pharm
- B.Sc / M.Sc Life Sciences
- Biotechnology / Biochemistry / Microbiology
- Clinical Research or related disciplines
- Fresh graduates and candidates with 0–2 years of experience may apply.