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Clinical Data Management

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Clinical Data Management in remote

  • Tata Consultancy Services
  • Full time
  • Email

Roles& Responsibilites: • Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan) • Provide support on clinical study database set-up, including eCRF design and database validation requirements. • Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements • Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks • Assist in reviewing and validating clinical data to ensure consistency, accuracy, integrity and completeness • Assist in create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) • Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc. • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data • Assist in medical coding tasks as assigned • Participate in conference calls and/or meetings with vendors and sponsors • Recognize and solve potential problems and evaluate effectiveness • Support and manage the database implementation, lock and close-out processes and procedures • Maintain documentation on an ongoing basis and ensure that all filing is up to date • Support planning and creating necessary documentation to support internal and external audits; participates in such audits assigned • Help to align data management and clinical programming best practices, standards and conventions within the company • Actively support staff learning & development within the company wherever appropriate. • Participate in applicable DM departmental meetings • Train and mentor less experienced data management staffs as appropriate. • Assist in proactively tracking data management development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes. Freshers can Apply

3 - 3.5 LPA



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