IQVIA Hiring Regulatory and Start-Up Specialist

The job opportunity for Regulatory and Start-Up Specialist 1 at IQVIA in Bengaluru, Karnataka, involves responsibilities in clinical operations and study start-up activities. Below is a summarized outline based on the information provided:

Job Title:

Regulatory and Start-Up Specialist 1
Location: Bengaluru, Karnataka
Employment Type: Full-Time

Job Responsibilities:

Key Responsibilities:

  • Survey Build: Create electronic surveys listing required study documents.
  • Package Build: Develop and manage electronic packages for essential and regulatory documents.
  • Query Tracking: Monitor and track regulatory queries using electronic systems.
  • Informed Consent Form (ICF) Development: Design ICF templates adhering to country-specific requirements.
  • Essential Document Review: Verify essential documents per country regulations.
  • Transactional Activities: Support activities like Clinical Study Report (CSR) preparation and Trial Master File Oversight.

Qualifications:

  • Educational Background:
    • Bachelor’s degree in healthcare or a scientific field is preferred, or equivalent experience.
  • Experience:
    • 1-2 years in clinical research with at least 1 year in study start-up activities.
    • Familiarity with ICF review, essential document verification, and regulatory submissions (IRB/IEC).
  • Skills:
    • Proficient in Excel.
    • Experience with systems like Vault Clinical or similar tracking tools.

About IQVIA:

IQVIA is a global leader in clinical research and healthcare intelligence, providing innovative solutions to life sciences industries to improve patient outcomes.

For more details, visit IQVIA Careers.

Application Link