Clinical Data Coordinator Lead

2 days ago

Hubli, Karnataka, India beBeeDataCoordinator Full time ₹ 40,00,000 - ₹ 85,00,000

Job Title: Clinical Data Coordinator Lead

Key Responsibilities:
  • Project management and control: Oversee project-specific and departmental document tracking and control activities to ensure timely completion.
  • Document review and verification: Conduct thorough reviews of CRF and project-specific documents as per protocol, identifying and addressing discrepancies in a timely manner.
  • Data management and integrity: Establish and maintain accurate project-specific DMTMF and e-filing systems, reviewing and updating them regularly to guarantee data validity.
  • Client support and coordination: Provide assistance to clients and the team in resolving issues and concerns in collaboration with the Project Manager.
  • Database design and validation: Collaborate with the CDA to conduct User Acceptance Testing (UAT) leading to robust database design and development.
  • Procedure verification and validation: Perform procedure verification as part of database validation to ensure accuracy and reliability.
  • Data clarification forms and updates: Develop, review, process, and track Data Clarification Forms to ensure data accuracy and update clinical databases accordingly.
  • Manual data listings: Prepare manual data listings as required.
  • Training and support for subordinates: Deliver project and process-specific training to subordinates, assisting in the maintenance of documents for Pre-production and Pre-lock audits.
  • Backup and review: Serve as a backup for the Data Manager, assisting in preparation and review of departmental SOPs.
  • Quality control and compliance: Conduct basic QC functions for departmental activities and ensure SOP compliance in project deliverables.
  • Regulatory compliance: Ensure adherence to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies for conducting delegated activities.

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