Clinical Data Management professional responsible for ensuring the accuracy, integrity, and completeness of clinical trial data throughout the study lifecycle. The role involves managing clinical databases, performing data review and cleaning activities, generating and resolving data queries, reconciling external vendor data, and supporting database lock activities. The candidate will collaborate with Clinical Operations, Biostatistics, Medical Writing, Programming, and Project Management teams to deliver high-quality clinical trial data in compliance with ICH-GCP, SOPs, and regulatory requirements.
Key Responsibilities:
Perform data review, validation, and query management activities.
Conduct data cleaning and discrepancy resolution.
Review and reconcile external vendor data (laboratory, ECG, imaging, etc.).
Support CRF and EDC design reviews, User Acceptance Testing (UAT), and database validation.
Prepare and maintain Data Management documents, Data Validation Plans, and study-specific guidelines.
Ensure compliance with ICH-GCP, CDISC standards, and company SOPs.
Participate in database lock, data transfers, and study closeout activities.
Generate data listings and reports to support clinical study deliverables.
Collaborate with cross-functional teams and stakeholders to resolve data-related issues.
Required Skills:
2+ years of Clinical Data Management experience.
Hands-on experience with EDC systems such as Medidata Rave, Inform, Oracle Clinical, or Veeva CDMS.
Strong understanding of Clinical Trial processes and GCP guidelines.
Experience in query management, data reconciliation, and database lock activities.
Knowledge of MedDRA and WHO Drug coding.
Familiarity with CDISC, SDTM, and clinical databases.
Excellent analytical, communication, and stakeholder management skills.
Education:
Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Biostatistics, or related disciplines.
Share CV to: [email protected]
Pay: ₹400,000.00 - ₹500,000.00 per year
Work Location: In person
