Regulatory Start Up Specialist Expert

4 days ago


Mumbai, Maharashtra, India IQVIA Full time

About This Role

We are seeking a highly skilled Regulatory Start Up Specialist Expert to join our team at IQVIA.

Job Summary

This is a critical role that involves working closely with regulatory bodies and internal stakeholders to ensure compliance and successful start-up of clinical studies. As a Regulatory Start Up Specialist Expert, you will be responsible for creating electronic survey builds, preparing and building electronic packages, tracking queries issued by regulatory bodies, and ensuring the completion of all defined transactional activities such as Clinical Study Reports (CSRs) and Trial Master File Oversight.

Key Responsibilities

  • Survey Build: Create electronic survey builds based on required documents needed for studies.
  • Package Build: Prepare and build electronic packages within our system for sites, including essential documents, regulatory documents, etc.
  • Query Tracking Process: Track queries issued by regulatory bodies within our electronic system.
  • Informed Consent Form (ICF) Build: Create ICF templates based on country requirements received from affiliates.
  • Essential Document Review: Review essential documents against checklists per country regulations.
  • Completion of Transactional Activities: Complete any other defined transactional activities such as CSRs and Trial Master File Oversight.

Requirements

  • Essential Skills and Qualifications: Strong understanding of regulatory requirements and processes, excellent communication skills, ability to work in a fast-paced environment, and strong analytical skills.
  • Preferred Qualifications: Experience working with regulatory agencies, knowledge of clinical trials, and proficiency in relevant software systems.

Benefits

We offer a competitive salary of $90,000 - $120,000 per year, depending on experience, plus benefits such as medical, dental, and vision insurance, 401(k) matching, and paid time off.

What We Offer

At IQVIA, we provide a dynamic and supportive work environment that encourages professional growth and development. We are committed to fostering a culture of diversity, equity, and inclusion and promoting opportunities for career advancement.



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