Study Data Manager

Job Code # 184

Job Location-  Mumbai

Salary- 10 LPA to 20 LPA

Key skills-
a) Experience in leading clinical studies.
b) Experience on Study Conduct and Close Out
c) Any Graduate

Job Description-
• Need exposure to Inform or Medidata Rave database
• Responsible & Accountable for the assigned study conduct activities, in clinical trials
• Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines.
• Generate data queries based on validation checks or raise Manual queries to resolve data inconsistencies.
• To perform reconciliation of data from external sources (e.g. Serious Adverse Events, IWRS, Central Laboratory).
• SPOC for the study communications
• Proactively highlight any risks associated with the study along with the mitigation plan.
• Establish a partnership with the stakeholders at the operational level to work seamlessly to deliver the assigned project/activity as per timelines.
• Identify process Improvement opportunities and ensure learning is shared
• Ensure deliverables and/or agreed activities/tasks with customers. are completed with the expected quality.
• Have worked on Study set-up, Study Conduct, and Study Closeout for various therapeutic areas.
• Have also worked on writing edit check specifications, CRF completion guidelines, and review and corrections of set-up documents for different versions