Cognizant is one of the world's leading professional services companies, transforming clients business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 193 on the Fortune 500 and is consistently listed among the most admired companies in the world.
Post : Team Leader
Job Description
• Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks
• Triage of Safety cases
• Oversight of data discrepancy management
• 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
• Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.
• 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
• Mange assigned activities to meet milestone dates
• Ask questions to get information needed to meet end goals
• Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)
Candidate Profile
• A Graduate / Post Graduate / Doctorate degree in Life sciences / Pharmacy / Medical sciences or equivalent degree
• Minimum 2 years to 6 years of experience in clinical data management
• Proactively communicate ownership of studies
• Critical thinking to identify root causes and best solutions for data discrepancy management
• Confidence to have tough conversations and make challenging decisions
• Enables an environment of open and honest communication and critical thinking within DSS study team
• Influence internal team to meet timelines by holding stakeholders accountable
• Ability to work with different personalities to get the work done
• Willingness to seek out information to accomplish goal
• Proactive communication
Additional Information
Qualification : Graduate / Post Graduate degree in Life Sciences / Pharmacy
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2021
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