WhatsApp Group Join Now
Telegram Group Join Now

Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

SHARE

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

IQVIA Hiring Regulatory and Start-Up Specialist
x