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Hiring for Clinical Data Management ( Team L ead- CDM )- Bangalore in Mumbai, Kolkata for Exp. 2 - 7 (Bangalore Job)

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Job Description:Please find the JD below for your reference. *Accountable for execution and on-time delivery of planned DSS milestones from study conduct through close-out *Creates relevant documents and data cleaning plan for all assigned trials (e.g., Integrated Data Review Plans, Clinical Database Specifications, Data Management Plans), when executed as designed, will produce a clinical-trial database that is fit for purpose and adequate for statistical analysis *Updates the data cleaning plan as necessary to maintain study health during trial conduct for all assigned trials *Responsible for ensuring operational triggers and study-level timelines are accurate and up to date in respective operational systems, while ensuring compliance and quality *Responsible for any audit findings regarding process execution or data integrity for any assigned clinical trial *Acts as team SME for key systems and processes *Responsible for preparing for monthly Health of Study milestones, which includes report generation, data discrepancy identification and trending, data reconciliation, slide preparation, action-item resolution *Responsible for monitoring and communicating any data management back log as it relates to discrepancy management, data reconciliation, data load issues, document readiness, DB versioning readiness, audit readiness *Accountable for 24 x 7 readiness immediately prior to database versioning (i.e. lock) for assigned trials. Responsible for versioning databases in a regulatory-compliant manner, in accord with DS SOPs, process design and timelines *Responsible for study close out activities as they relate to system access (i.e., read-only), decommissioning, TMF/ eTMF readiness *Coordinates any post-lock database version changes *Contributes to Data and Statistical Sciences Study and Program level huddles *Accountable for Good Documentation Practices in every aspect of the operations *Accountable for supporting and utilizing Data Sciences policies and procedures *Reports into the Therapeutic Area Associate Director level in DS


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Posted on: Thursday, 06 April, 2017  08:43
Expires On: Tuesday, 24 December, 2019  18:30

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