Associate Manager - Clinical Data Management
TCS · Mumbai
Source and collection record
Last observed by our collector: . This is not a manual review or a confirmation from the employer.
Employer requisition: 434941
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Collected role description
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. <p listparagraphcxspmiddle"="" style="margin-bottom:0cm;mso-add-space: auto;text-align:justify;text-indent:-18
Collected minimum qualification
BACHELOR OF PHARMACY, BACHELOR OF SCIENCE ( B.Sc Degree ), MASTER OF PHARMACY, MASTER OF SCIENCE
Collected experience requirement
8 - 13 Years