Senior Analyst, Data Acquisition

3 - 4 years

20 - 25 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Performs the study set-up activities and the technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical study(ies).
  • Assist with the technical & vendor oversight of multiple data types for one or more clinical study(ies).
  • Support the delivery of one or more Clinical studies depending upon the phase, complexity, and similarity with support of junior data acquisitions staffs as required.
  • For studies, key responsibilities include:
  • Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
  • Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations).
  • Understands, mediates and solves issues related to Data acquisition Develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time.
  • Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities.
  • Ensures quality control of deliverables.
  • Provide inputs to process improvements, new processes, training, quality assessments, audits and inspections related to the Data Acquisition.
  • Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.
  • Extensive working knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable).

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GSK India

Pharmaceuticals & Biotechnology

Mumbai

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