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manish srivastava

manish srivastava

Clinical Data Manager

Pharmaceutical / Bio-tech

Colchester, Colchester District, Essex

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About manish srivastava:

Having 7+ years of experience in the Clinical Data Management field.

  • Applied critical analysis and exceptional communication skills to design data collection solutions for clinical trial sponsors.
  • Knowledge in Medical Coding with MedDRA and WHO Drug
  • Successfully designed Edit Checks, and Query logic and conducted User Acceptance Testing (UAT).
  • A considerable amount of experience with phases I through III of clinical trials using EDC (electronic data capture).
  • Well-versed in ICH-GCP and 21 CRF Part 11 guidelines.
  • Working experience in developing Data Transfer Agreements with external vendors.

Experience

Having 7+ years of experience in the Clinical Data Management field.

  • Applied critical analysis and exceptional communication skills to design data collection solutions for clinical trial sponsors.
  • Knowledge in Medical Coding with MedDRA and WHO Drug
  • Successfully designed Edit Checks, and Query logic and conducted User Acceptance Testing (UAT).
  • A considerable amount of experience with phases I through III of clinical trials using EDC (electronic data capture).
  • Well-versed in ICH-GCP and 21 CRF Part 11 guidelines.
  • Working experience in developing Data Transfer Agreements with external vendors.

Education

Master in Business Administration From Wales University.

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