Cognizant Clinical Data Management Job – Candidates Apply Online
Joining Cognizant’s Clinical Data Management team, you will support Pharma companies in handling their data related to adverse effects or drug-related problems to help them stay ahead of their competition. Everyone is invited to challenge convention, and this role is no exception.
Job Title: Team Leader
Location: Mumbai, Maharashtra, India
Job ID: 00045169902
Eligibility Criteria:Â
- A Graduate/Post Graduate/Doctorate degree in 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
Your role
As a Data Analyst, you’ll work on a project, with responsibility for:
- Perform Migrations / Set up / Closeout activities apart from Study Conduct activities under the supervision and quality checks
- Triage of Safety cases
- Oversight of data discrepancy management
- Owner of study documentation, including completeness, accuracy, and perform a 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 is 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 the 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 the 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 the 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)
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