Job Description

nAbout the Company
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nJob Description
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nAbout the Role
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nJob Title: Associate Manager, Clinical Data Management
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nKey Accountabilities Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes.
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nResponsibilities
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- These activities may include the following categories:n

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nData Review
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- May perform one of more of the following:n
- Performs data review of clinical trial data, including query management. Communicates with study team members and CRO (Contract Research Organization) to resolve queries.n
- 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.n
- May include the following:n
- Acts as liaison between client CRO and eCOA vendor/external data vendor.n
- Ensures accessibility of eCOA/external data to all relevant client and CRO team.n




- QCs a sample of data clarification requests processed by the eCOA/external data vendor.n
- Maintains eCOA/external data issues within the centralized study data issues log.n
- Ensures appropriate and timely communication of eCOA/external data related issues and resolutions to relevant client and CRO team.n
- Performs reconciliation review of eCOA/external data against EDC data and works with applicable parties to resolve queries.n
- Performs SAE (Responsible Adverse Event) reconciliation and communicates with applicable safety team members to resolve issues.n
- 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.n
- Contributes to the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specificat

📌 Associate Manager Clinical Data Management (Kozhikode)
🏢 CosMicIT
📍 Kozhikode