Lead clinical data management activities across assigned clinical trials, ensuring high-quality data acquisition, database design, and data integrity.
Act as a technical resource for Data Management (DM) and Risk-Based Monitoring (RBM) standards, tools, and reporting.
Collaborate with cross-functional teams, external vendors, and internal stakeholders to ensure timely, compliant, and efficient data management processes.
Ensure study-specific documentation is complete and maintained in the Trial Master File (TMF).
Support data cleaning, integrity monitoring, e-data processing, and database release according to SOPs and industry best practices.
Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Clinical Research, or related field.
3+ years of experience in Clinical Data Management within the pharmaceutical or CRO industry.
Strong knowledge of EDC systems, clinical trial processes, and regulatory compliance (ICH-GCP).
Experience in Risk-Based Monitoring (RBM), data cleaning, and data visualization tools.
Excellent analytical, communication, and problem-solving skills.
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Lead Data Scientist • Kollam, IN
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