Associate Manager - Clinical Data Management

TCS is Hiring

Role : Associate Manager – CDM

Responsibilities

Data Review

·         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 client CRO and eCOA vendor/external data vendor.

·         Ensures accessibility of eCOA/external data to all relevant client and 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 client and 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 issues.

·         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.

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