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.
Source: Tata Consultancy Services careers — Read the original posting and apply
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