Clinical Database Manager

• Manage and oversee all aspects of clinical data management (CDM) activities for assigned clinical studies. ​

• Develop and review Data Management Plans (DMPs) , CRF designs , edit checks , and data validation plans . ​

• Ensure timely data cleaning, Query Management, Data review, Data/SAE Reconciliation, Database lock, and delivery of high-quality datasets . ​

• Expertise in creating and maintaining the essential documents in eTMF or equivalent documents repositories in compliance with good documentation practices. ​

• Collaborate closely with cross-functional teams, including database developer, Report Programmers, biostatistics and clinical operations. ​

• Serve as a subject matter expert (SME) for assigned EDC systems (e.g., Medidata Rave, Veeva, InForm /CD or similar) . ​

• Perform data review, discrepancy management, and validation per study timelines and SOPs. ​

• Coordinate with vendors, CROs, and internal stakeholders for database development and testing. ​

• Provide thought leadership and contribute to process improvements, automation, and standardization initiatives. ​

• Mentor junior data managers and contribute to team development activities. ​

Must have

• 8–12 years of relevant experience in Clinical Data Management in the pharmaceutical, CRO, or biotech industry. ​

• Strong knowledge of EDC systems (Medidata Rave preferred). ​

• Experience with metadata management, CRF annotation , and data validation . ​

• Deep understanding of CDISC/CDASH standards , GCP , and clinical data workflows . ​

• Excellent communication and interpersonal skills to collaborate with cross-functional teams. ​

• Proven ability to handle multiple projects , meet deadlines, and maintain data quality. ​

• Experience leading data management activities or mentoring team members is highly desirable.

Educational Background

• Minimum qualification: Bachelor’s degree (10+2+3) in Life Sciences, Clinical Research, Microbiology, Biotechnology, or a related discipline. ​

• Master’s degree in Clinical Research, Life Sciences, Biomedical Science, or any other related scientific field is preferred.