IQVIA is a global leader in clinical research, commercial insights, and healthcare intelligence, committed to accelerating the development of innovative medical treatments. With its focus on improving patient outcomes and advancing population health, IQVIA offers cutting-edge solutions to the life sciences and healthcare industries. At IQVIA, you’ll be part of a team that’s shaping the future of healthcare.
Responsibilities in the Job
As a Regulatory & Start-Up Specialist 1, you will play a crucial role in driving efficient and effective global study start-up activities. Your responsibilities will include:
- Survey Build: Designing and creating electronic survey builds for required study documents.
- Package Build: Preparing and organizing electronic packages for sites, including essential and regulatory documents.
- Query Tracking: Tracking queries raised by regulatory bodies within the electronic system.
- Informed Consent Form (ICF) Build: Developing ICF templates tailored to country-specific requirements.
- Essential Document Review: Ensuring compliance with country regulations by reviewing documents against checklists.
- Transactional Activities: Supporting Clinical Study Report (CSR) and Trial Master File Oversight processes.
Qualifications and Skills
To excel in this role, you should have:
- Educational Background: A Bachelor’s Degree in a healthcare or scientific field is highly preferred. Equivalent experience will also be considered.
- Clinical Research Experience: 1-2 years of clinical research experience and at least 1 year of study start-up experience.
- Technical Expertise: Proficiency in Microsoft Excel and prior experience working with Vault Clinical or similar tracking systems.
- Specific Skills:
- Experience with Informed Consent Form (ICF) reviews.
- Knowledge of reviewing essential documents.
- Familiarity with IRB/IEC and competent authority submissions and approvals.
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