Clinical Data management - MumbaiPuneHyderabad
Clinical Data management - MumbaiPuneHyderabad
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Job Description
Joining our Clinical Data Management team you will support Pharma companies in handling their data related to adverse effects or related problems to help them stay ahead of their competition.
Your role
As a Data Analyst you ll work on a project with responsibility for:
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 studyspecific 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 termlong term reconciliation)
Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)
Manage global and studyspecific 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
o Brings CDR DWA and SD together to discuss postproduction 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
What you need
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
Mortgage
Education
Any
Employment Type
Full Time
