Clinical Data Management (Advanced)
On-site · Bengaluru, Karnataka, India or Chennai, Tamil Nadu, India
Job Summary
Lead and perform complex scientific clinical data review at trial and program levels, collaborating with SRP/SRS to review data, resolve eDC queries, and ensure data accuracy and completeness. Oversee data flows and Data Management Plans while performing continuous, in-depth data review activities. Contribute to protocol design and provide input into eCRFs and data collection tools. Align data review expectations and timelines with SRP/SRS, GDM, CROs, and cross-functional stakeholders. Define data quality standards and ensure timely delivery of all CDM milestones; develop and maintain the Integrated Review Plan to ensure regulatory compliance. Ensure inspection readiness and actively support audits and health authority inspections. Provide program-level leadership by supporting DMLs in planning, resource allocation, and cross-functional collaboration. Drive quality and continuous improvement by implementing best practices and leading process, system, and tool enhancements.
Required Qualifications
- Bachelor’s degree in Life Sciences or related field
- 5+ years of Clinical Data Management experience
- strong expertise in scientific data review
- leadership capabilities at study or program level
- stakeholder and resource management
- proficiency in eDC and clinical data systems
- strong analytical, communication, and problem-solving skills
- commitment to regulatory requirements (ICH-GCP)
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