Regulatory and Start-Up Specialist 1 at IQVIA
Location: Bengaluru, Karnataka
Company: IQVIA
Job Type: Full-Time
Experience: 1-2 years
Qualification: B.Pharm / M.Pharm / MSc / BSc
IQVIA is hiring a Regulatory and Start-Up Specialist 1 to join their team in Bengaluru, Karnataka. This role involves managing clinical operations and study start-up activities. Below are the details of the position: Regulatory and Start-Up Specialist 1 at IQVIA
Job Responsibilities
As a Regulatory and Start-Up Specialist 1, your key responsibilities will include:
- 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 in compliance with country-specific requirements.
- Essential Document Review: Verify essential documents according to country regulations.
- Transactional Activities: Support activities like Clinical Study Report (CSR) preparation and Trial Master File (TMF) oversight.
Regulatory and Start-Up Specialist 1 at IQVIA
Qualifications
Educational Background
- Bachelor’s degree in healthcare or a scientific field (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
- Proficiency in Excel.
- Experience with systems like Vault Clinical or similar tracking tools.
Why Join IQVIA?
- Work/Life Balance
- Time Management
- Flexibility
- Problem-Solving
IQVIA is a global leader in clinical research and healthcare intelligence, providing innovative solutions that improve patient outcomes across the life sciences industry. Regulatory and Start-Up Specialist 1 at IQVIA
How to Apply
For more details and to apply, visit the IQVIA Careers website.
Don’t miss out on the chance to be part of a global leader in clinical research!
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