Regulatory Start Up Specialist IQVIA Bangalore
Job Highlights
- Position: Regulatory & Start-Up Specialist
- Company: IQVIA
- Location: Bangalore, India
- Experience: 1-2 years
- Qualification: B.Pharm, M.Pharm, MSc, BSc
- Job Type: Verified Online Application
Job Overview
The role focuses on collaborating with the Clinical Study Start-Up (CSS) team to streamline global study start-up activities through document preparation, regulatory submissions, and system builds.
Key Responsibilities
- Survey Build: Develop electronic surveys listing key study documents as per study requirements.
- Package Build: Prepare electronic packages for sites, including essential and regulatory documents.
- Query Tracking: Monitor and address queries from regulatory bodies within the electronic system.
- Informed Consent Form (ICF) Build: Create country-specific ICF templates.
- Essential Document Review: Evaluate essential documents against regulatory checklists.
- Additional Tasks: Support Clinical Study Report (CSR) preparation and Trial Master File Oversight.
Required Qualifications
- Education:
- Bachelor’s degree in healthcare/science field preferred.
- Equivalent experience may be considered.
- Experience:
- 1-2 years in clinical research.
- At least 1 year in study start-up activities.
- Hands-on experience with ICF review and essential document assessment.
- Familiarity with IRB/IEC and authority submissions.
- Experience with Vault Clinical or similar systems.
- Skills:
- Proficiency in Excel.
Why Join IQVIA?
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. By joining, you’ll contribute to accelerating the development and delivery of innovative medical treatments that improve patient outcomes globally. Regulatory Start Up Specialist IQVIA Bangalore
Apply online to be part of a team that’s shaping the future of healthcare and life sciences! Regulatory Start Up Specialist IQVIA Bangalore
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