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12.0 - 15.0 years
22 - 25 Lacs
chennai
Work from Office
Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, ...
Posted 1 month ago
10.0 - 15.0 years
20 - 35 Lacs
chennai
Work from Office
Position Overview We are seeking an experienced Senior Clinical Data Manager to support our clinical data management team in Chennai. The successful candidate will work as Subject Matter Expert (SME) for CRIO CTMS including e-Source creation, edit, oversee and mentor the end-to-end clinical trial management system activities, ensuring seamless integration between CTMS, EDC platforms, and clinical operations. Key Responsibilities CTMS Operations & Strategy Develop and maintain e-source, CTMS workflows, user roles, and system permissions. Ensure integration between CTMS and EDC systems for seamless data flow. Lead system upgrades, validation activities, and change control processes. Establish ...
Posted 1 month ago
4.0 - 9.0 years
12 - 15 Lacs
chennai
Work from Office
Position Overview We are seeking an experienced Clinical Data Specialist II to join our clinical research team in Chennai. The successful candidate will be responsible for accurate and timely data entry into Electronic Data Capture (EDC) systems from various e-source documents, including real-time data and Clinical Research Information Officer (CRIO) sources. Key Responsibilities Data Management Perform accurate data entry into EDC systems from e-source documents (Real-time & CRIO). Conduct data verification and validation to ensure data integrity. Execute data reconciliation activities between different data sources & EDC. Maintain detailed logs of data entry activities and progress trackin...
Posted 1 month ago
12.0 - 15.0 years
22 - 25 Lacs
Chennai
Work from Office
Team Leadership & Oversight Support and mentor a team of Clinical Data Specialists, promoting consistency, quality, and productivity. Collaborate on training plans, performance goals, and team development. Provide day-to-day guidance and technical support related to data issues. Help manage team capacity, workload distribution, and scheduling across studies. Foster effective collaboration with cross-functional teams. Data Management & Quality Assurance Accurate data maintenance, quality control, and discrepancy resolution in CTMS and EDC systems (e.g., RAVE, Veeva Vault, Clinical One, Inform). Review source documents for adherence to ALCOA-C principles and regulatory guidelines (GCP, HIPAA, ...
Posted 4 months ago
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