Clinical Data Management

Cognizant Technology Solutions
  • Mumbai, Navi Mumbai
  • Confidential
  • 3-7 years
  • Views
  • 05 Oct 2018

  • Others

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Walkin Drive on 3rd Oct from 10:30 AM to 11:30 AM

Venue: Building 9, 2nd Floor Airoli Mindspace Navi Mumbai

Oversight of data discrepancy management
Experience in Clinical Data Management preferably in Conduct and/or Close-out activities
Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF
Responsible for compiling HoS content
Conduct the protocol amendment impact assessment and complete appropriate documentation
Manage migration and audit trail reports
Create slides for study-specific EDC investigator training
Provide study specific training to data manager (DM)
Contribute to the Data Management Plan (DMP)
Request DTS creation and ensure DTS finalized and complete for any LSH loads
Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)
Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)
Manage global and study-specific data entry conventions
Facilitate versioning, including:
Unlock/audit trail review
Archival process
Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design
Timely communication with key stakeholders on issues and risks, including
Brings CDR, DWA, and SD together to discuss post-production changes when identified
Provide critical information to PL who will communicate with study team
Log any action issues into DS Hub and resolve outstanding issues assigned to DA



Competencies/Skill sets for this job

Clinical Data Management Close - Out Conduct

Job Posted By

Clement
Director Projects

About Organisation

Cognizant Technology Solutions