Job Description:

  • Responsible for processing complete Study
  • Evaluating Team quality and submitting an improvement area to Mangers for course correction.
  • Providing Inputs regarding CDM Activities to all stakeholders, of study assigned.
  • Guiding Team on Automation for the smooth accomplishment of work.
  • Preparation and QC of the eCRF specification of the team members.
  • Study and Review protocols & CRF’s
  • Preparation and Review of Data Validation Specification (DVS).
  • Preparation and review of manual listing of the study
  • Preparation and review of eCRF Completion guidelines
  • Preparation and review of Data Management Plan (DMP)
  • Create and review of the test scripts for the UAT (User Acceptance Testing)
  • Performing UAT of the edit checks and screens review of the study.
  • Performing the Data Management activities of the studies like query management which includes query generation and query resolution.
  • Performing external data reconciliations (SAE and Lab data).
  • Generating metrics reports/study status reports for the DM status of the study and updating the stakeholders of the study.
  • Documentation of the study activities as per SOP and regulatory guidelines.
  • Freezing and Locking of the database.
  • Assisting team in all Data Management activities for the assigned studies and helping in other study UAT and closeout activities when required.
  • Performing the Post-production changes and assessing the impact of the changes.
  • Decision-making capabilities in providing the DM related solution to the study team as applicable.

Qualification: Appropriately Qualified

Experience: 1-3 Years

Salary: Negotiable

Contact Details:

snehal.mashale@teva.co.in

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