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Report Writer

4 weeks ago

Ahmedabad, India Veeda CR Full time

Role & responsibilities

  • Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates.
  • Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements.
  • Submit final compilation signed report with e-CTD to client.
  • Co-ordinate with Project Manager for report requirement, sponsor's comments & response.
  • Draft final report and submit to sponsors via project manager. Co-ordinate with BR for bio analytical report and stat for statistical report and submit sponsors via project manager.