Clinical Data Management Specialist

Clinical Data Management

Mumbai

7 to 12 Years

Skillset Required- Knowledge of medical device risk classification

Education

UG:

PG:

Interested candidates are requested share updated CV with below details on the mail id – s.laharika@tcs.com

Key Responsibilities

Review and understand the study protocol and the timelines.

Perform data review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate.

Implement study team feedback as required on the data.

Perform external checks to handle manual discrepancies and action the same.

Develop specifications, implementation and testing for the edit checks and listings (DVS)

Perform UAT for database

Develop study specific procedures documents

Ensure effective implementation of standard metric and status reporting on the study

Ensure an error free, quality data with no open queries.

Maintain data management study files and documentation

Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor

Identify out of scope tasks and bring to the attention of the TDM

Assist the TDM in all study set up activities.

Provide all study related reports to the TDM as per the request .

. Perform SAE reconciliation and Vendor data reconciliation

Regards,

Laharika-TCS HR