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.