Tcs job opening for Clinical Research Coordinator and Clinical Data Management

Clinical Research Coordinator in remote

Job Describtion : An exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. You would work in a new established group, that provides support for study teams of Phase I – Phase IV (interventional & non-interventional) and Investigator Sponsored Studies with and without CRO involvement. As a Clinical Trial Coordinator, you will manage activities within a dedicated Center of Excellence for operational deliverables of Clinical Studies with interactions of multiple cross functional Biopharma functions and CROs.

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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