Roles & Responsibilities:
• Support end-to-end Clinical Data Management activities across multiple clinical studies.
• Assist in database testing, UAT, and validation prior to study activation.
• Prepare, review, and maintain study-specific Data Management documents.
• Review CRFs to identify inconsistencies, missing data, and data discrepancies.
• Raise, track, and resolve data queries and Data Clarification Forms (DCFs).
• Perform quality control checks on data entry, listings, and database outputs.
• Manage self-evident queries and allowable data changes as per guidelines.
• Support study close-out activities and archival documentation.
• Ensure compliance with ICH-GCP, SOPs, regulatory requirements, and client standards.
• Perform medical coding activities when assigned.
• Coordinate with offshore data processing, programming, and project teams.
• Provide regular project updates using reports, metrics, and dashboards.
Qualification:
• Graduate or Postgraduate degree in Life Sciences, Pharmacy, or a related discipline
Experience:
• Prior experience in Clinical Data Management or a similar role
• Hands-on experience with at least one CDM system such as Medidata Rave, Oracle Clinical, or Inform
Skills:
• Strong understanding of CDM processes and regulatory requirements
• Excellent attention to detail and analytical skills
• Good written and verbal communication skills
• Proficiency in MS Word and MS Excel
• Ability to manage multiple priorities in a fast-paced environment
About the Organization:
Quanticate is a world-leading, data-focused Contract Research Organization (CRO) specializing in clinical data management, statistical programming, and biometrics services, supporting global clinical trials with a strong emphasis on data quality, regulatory compliance, and innovative data solutions.
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