Tcs job opening for Clinical Data Management in remote Freshers can Apply apply now

Tcs job opening for Clinical Data Management in remote apply now

Clinical Data Management in remote

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