Associate CDM Manager

Tata Consultancy Services Limited; Mumbai; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Résumé du poste

Tata Consultancy Services Limited is seeking an Associate Manager – Clinical Data Management to lead data review, cleaning, and reconciliation activities in clinical trials. You will coordinate with CROs and vendors, oversee SAE reconciliation, and help ensure data integrity across EDC, eCOA/ePRO, and other data sources.

You will also contribute to the development of data management plans, support system validation and database locks, and maintain regulatory-compliant study documentation in eTMF

Qualifications

• Clinical data management experience preferred.
• Familiarity with SOPs and GxP advantageous.

Responsabilités

• Perform clinical trial data review, query management, and data cleaning as per SOPs and study plans.
• Review and reconcile EDC, eCOA/ePRO and external/vendor data; coordinate with CROs, vendors, and study teams to resolve data issues.
• Perform SAE reconciliation and coordinate with Safety teams for issue resolution.
• Support preparation/maintenance of Data Cleaning Plans, Data Validation Plans/edit checks, data transfer/integration specifications, reconciliation plans, coding guidelines, and database lock plans.
• Support interim and final database locks.
• Support setup and testing of clinical data collection systems such as EDC, IRT, eCOA and ePRO.
• Maintain study documentation in eTMF, conduct QC reviews, support data archival and inspection-readiness activities.
• Monitor data-management metrics and escalate issues where required.
• Perform quality review of CRO activities and coordinate/mentor other Data Coordinators.
• Ensure compliance with SOPs, GxP and applicable regulatory requirements.

Description du poste

Associate Manager – Clinical Data Management

Key Responsibilities:

• Perform clinical trial data review, query management, and data cleaning as per SOPs and study plans.
• Review and reconcile EDC, eCOA/ePRO and external/vendor data; coordinate with CROs, vendors, and study teams to resolve data issues.
• Perform SAE reconciliation and coordinate with Safety teams for issue resolution.
• Support preparation/maintenance of Data Cleaning Plans, Data Validation Plans/edit checks, data transfer/integration specifications, reconciliation plans, coding guidelines, and database lock plans.
• Support interim and final database locks.
• Support setup and testing of clinical data collection systems such as EDC, IRT, eCOA and ePRO.
• Maintain study documentation in eTMF, conduct QC reviews, support data archival and inspection-readiness activities.
• Monitor data-management metrics and escalate issues where required.
• Perform quality review of CRO activities and coordinate/mentor other Data Coordinators.
• Ensure compliance with SOPs, GxP and applicable regulatory requirements.