Ajinkya Bhalekar

Experience

• 

  FDA

  Jun 2019 - Aug 2019

  Internship Program

  i learn alot about testing labs how they work complying to GLP.Hands on training on instruments like HPLC, HPTLC, UV, FTIR, TGA, Dissolution and Disintegration also calibrations of all above instrumnets.microbial assay such as MLT, bioassay, sterility testing.we were following standards and complying to FSSAI and Indian pharmacopoeia monographs. we were ensuring that the product is matching standards and it is safe for the society or not.

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  Alembic Pharmaceuticals Limited

  Jun 2020 - Jan 2021

  Medical Representative
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  IQVIA

  Feb 2021 - now

  RESPONSIBILITIES1. Conduct basic data review.2. Write data clarifications as directed by the Data Operations Coordinator.3. Resolve data clarifications, as directed by the Data Operations Coordinator.4. Conduct basic quality control procedures.5. Meet personal project objectives, as assigned by manager.6. Escalate problems to the attention of the Data Operations Coordinator or Group Manager.7. Understand and comply with core operating procedures and working instructions.8. Understand, provide input to and comply with all applicable sections of Data Management Plan.9. Understand basic database structures. 10. Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (AE/CM compares, Inclusion/Exclusion review, etc.), Aggregate Checks (DM listings), and Reconciliation (LAB and other vendors).11. Produce and Review Metric reports for internal/external project team12.Develop and maintain good communications and working relationships with CDM team. Show less

  • Clinical Data Specialist

    Jul 2024 - now

  • Associate Clinical data coordinator

    Feb 2022 - Jul 2024

  • Trainee clinical Data coordinator

    Feb 2021 - Feb 2022