About the Company
Job Description
About the Role
Job Title: Associate Manager, Clinical Data Management
Key Accountabilities Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes.
Responsibilities
These activities may include the following categories: 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 e COA/external data per the Date Review Plan and works closely with the vendor and CRO to resolve e COA/external data related issues. May include the following: Acts as liaison between client CRO and e COA vendor/external data vendor. Ensures accessibility of e COA/external data to all relevant client and CRO team. QCs a sample of data clarification requests processed by the e COA/external data vendor.



Maintains e COA/external data issues within the centralized study data issues log. Ensures appropriate and timely communication of e COA/external data related issues and resolutions to relevant client and CRO team. Performs reconciliation review of e COA/external data against EDC data and works with applicable parties to resolve queries. Performs SAE (Reliable 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. 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 addi

📌 Associate manager clinical data management (Madhya Pradesh)
🏢 CosMicIT
📍 Madhya Pradesh