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Clinical Development Associate

7 days ago


Pune, Maharashtra, India TransPerfect Full time

About the Role

We are seeking a highly motivated and detail-oriented Clinical Document Specialist I to join our team. As a Clinical Document Specialist I, you will play a critical role in reviewing and managing clinical trial documents.

Responsibilities

  • Review and index TMF documents for accuracy and completeness
  • Ensure compliance with regulatory requirements and sponsor expectations
  • Communicate effectively with stakeholders to resolve queries and issues
  • Maintain accurate and up-to-date project documentation
  • Assist with user acceptance testing and product development

Required Skills and Qualifications

  • Knowledge of clinical development phases and processes, including GCP and ICH regulations
  • Understanding of essential documents and clinical study documentation
  • Superior written and spoken communication skills in English
  • Proficiency in Microsoft Office and eClinical technologies
  • Minimum bachelor's degree or equivalent
  • Up to 1 year of experience in the Life Sciences industry

Company Overview

At TransPerfect, we are committed to providing innovative solutions for global business needs. Our team is dedicated to delivering exceptional service and supporting our clients' success.