Role & responsibilities:
- Design, develop, and review eCRFs based on study protocols.
- Prepare and implement edit checks and data validation specifications.
- Develop and maintain Data Management Plans (DMPs).
- Perform clinical data review, discrepancy management, query generation, and data cleaning.
- Support database build, testing, UAT, database lock, and study closeout activities.
- Work closely with Clinical, Medical, Biostatistics, and Programming teams.
- Maintain data quality and ensure compliance with applicable GCP, CDISC, and regulatory requirements.
- Manage clinical databases using tools such as Clinion, Rave (EDC), Oracle Clinical, and other clinical data management platforms.
Requirements:
- Strong experience in eCRF creation, edit checks, DMP preparation, data cleaning, and database management.
- Experience with Crinion, Medidata Rave, Oracle Clinical, or similar EDC/CDM tools.
- Good understanding of clinical trial processes and CDM standards.
- Robust attention to detail, analytical skills, and ability to work effectively in cross-functional teams.
Preferred candidate profile can send to email:
[email protected]
📌 Clinical Data Management (Data Analyst) (Hyderabad)
🏢 QPS Bioserve
📍 Hyderabad