Associate Manager - CDM

TCS is hiring for  Associate Manager - CDM

Job Location – Hyderabad/Noida/Mumbai/Bangalore/Pune

Experience Range – 8 to 17 Years

Skillset Required - Veeva/EDC, Rave, Conducting, Closing Out

Educational Qualification(s) Required – Life Science Graduate

Roles & Responsibilities

May perform one of more of the following:

* Performs data review of clinical trial data, including query management. Communicates with   study team members and CRO (Contract Research Organization) to resolve queries.

 * Performs detailed review of eCOA/external data per the Date Review Plan and works closely with the vendor and CRO to resolve eCOA/external data related issues.

May include the following:

 • Acts as liaison between , CRO and eCOA vendor/external data vendor.

• Ensures accessibility of eCOA/external data to all relevant  CRO team.

 • QCs a sample of data clarification requests processed by the eCOA/external data vendor.

 • Maintains eCOA/external data issues within the centralized study data issues log.

• Ensures appropriate and timely communication of eCOA/external data related issues and resolutions to relevant  CRO team.

* Performs reconciliation review of eCOA/external data against EDC data and works with applicable parties to resolve queries.

* Performs SAE (Serious Adverse Event) reconciliation and communicates with applicable safety team members to resolve is sues.

* May prepare and distribute performance metrics (e.g. site completion of data entry and resolution of queries) to applicable stakeholders. Escalates to CDM Lead and study team as needed.

 * Contributes to the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.

 * Performs additional review activities for interim and final database locks as needed.