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Clinical Data Management- Data Analyst

Mumbai, MH
Job Code:
  • IT
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Job Details

Accountable for execution and on-time delivery of planned DSS milestones from study conduct through close-outCreates 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 analysisUpdates the data cleaning plan as necessary to maintain study health during trial conduct for all assigned trialsResponsible for ensuring operational triggers and study-level timelines are accurate and up to date in respective operational systems, while ensuring compliance and qualityResponsible for any audit findings regarding process execution or data integrity for any assigned clinical trial Acts as team SME for key systems and processesResponsible for preparing for monthly Health of Study milestones, which includes report generation, data discrepancy identification and trending, data reconciliation, slide preparation, action-item resolutionResponsible 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 readinessAccountable 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 timelinesResponsible 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 huddlesAccountable for Good Documentation Practices in every aspect of the operationsAccountable for supporting and utilizing Data Sciences policies and procedures Reports into the Therapeutic Area Associate Director level in DSMinimum EducationBachelor's degree in business, management information systems, computer science, life sciences, mathematics, statistics, or equivalent is requiredMaster's degree is desired Minimum Experience / Training RequiredMandatory - Must have 2+ years of direct data management experience or 4+ years of experience in a similar technical environmentMust have ability to convert statistical analysis needs to data requirements Demonstrated effective communication skills, emotional intelligence, and leadership traitsDemonstrated analytical skills plus ability to learn to use clinical analytics tools in the identification of signals and potential issues with clinical trial dataDemonstrated success supporting and executing global program(s) in a fast-paced 24 x 7 environment, managing multiple priorities effectively
Additional Degree: BE/ B.Tech (Engineering)

Experience: 4-9


Application Programming | Business/Systems Analysis | Database Administration (DBA) | Software Engineer
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