Job Location: Mumbai
Data Analyst
At Cognizant, weโre creating a culture that enables exceptional outcomes. Forget business as usual. This is about pursuing some of the worldโs most exciting, cutting-edge technologies; inspired solutions that enhance the lives of millions across the globe. Our workplace thrives on ideas and opportunities. Everyone is invited to challenge convention, and this role is no exception.
Joining our Clinical Data Management team, you will support Pharma companies in handling their data related to adverse effects or drugs related problems to help them stay ahead of their competition.
Your role
As a Data Analyst, youโll work on a project, with responsibility for:
โข Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks
โข Triage of Safety cases
โข Oversight of data discrepancy management
โข Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF
โข Responsible for compiling HoS content
โข Conduct the protocol amendment impact assessment and complete appropriate documentation
โข Manage migration and audit trail reports
โข Create slides for study-specific EDC investigator training
โข Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.
โข Provide study specific training to data manager (DM)
โข Contribute to the Data Management Plan (DMP)
โข Request DTS creation and ensure DTS finalized and complete for any LSH loads
โข Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)
โข Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)
โข Manage global and study-specific data entry conventions
โข Facilitate versioning, including Unlock/audit trail review & Archival process
โข Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design
โข Timely communication with key stakeholders on issues and risks, including
o Brings CDR, DWA, and SD together to discuss post-production changes when identified
โข Provide critical information to PL who will communicate with study team
โข Log any action issues into DS Hub and resolve outstanding issues assigned to DA
โข Mange assigned activities to meet milestone dates
โข Ask questions to get information needed to meet end goals
โข Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)
What you need
โข A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree
โข Minimum 2 years to 6 years of experience in clinical data management
โข Proactively communicate ownership of studies
โข Critical thinking to identify root causes and best solutions for data discrepancy management
โข Confidence to have tough conversations and make challenging decisions
โข Enables an environment of open and honest communication and critical thinking within DSS study team
โข Influence internal team to meet timelines by holding stakeholders accountable
โข Ability to work with different personalities to get the work done
โข Willingness to seek out information to accomplish goal
โข Proactive communication
Join us on our remarkable journey by applying right here.
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