Clinical Database Manager
1 day ago
What we are looking for
We are seeking an experienced Clinical Data Manager (CDM) / Lead Clinical Data Manager to join our growing clinical data management team. The ideal candidate will have a strong background in end-to-end data management , EDC systems (preferably Medidata Rave, Veeva, InForm /CD or similar) , and experience leading or mentoring data management teams. This role will be office- based in Gurugram , with close collaboration with leadership and cross-functional teams to ensure data integrity, compliance, and quality throughout clinical studies.
What you'll do
- 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 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.
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