Are you ready to advance your career in clinical operations? IQVIA, a global leader in clinical research services and healthcare intelligence, is hiring for the position of Regulatory & Start-Up Specialist I in Bengaluru, Karnataka. This full-time opportunity is perfect for individuals passionate about accelerating medical research and improving healthcare outcomes.
About IQVIA
IQVIA combines advanced analytics, technology, and unparalleled healthcare insights to help life sciences organizations innovate and improve patient outcomes. With a global footprint and a commitment to fostering talent, IQVIA offers professionals a platform to excel and make a tangible impact on population health.
Key Responsibilities
As a Regulatory & Start-Up Specialist I, you will play a pivotal role in streamlining study start-up activities globally. Your responsibilities include:
- Survey Build: Creating electronic surveys for key study documents based on requirements.
- Package Build: Preparing and building electronic packages containing essential and regulatory documents for sites.
- Query Tracking: Monitoring and tracking queries raised by regulatory bodies in the electronic system.
- Informed Consent Form (ICF) Development: Crafting ICF templates tailored to specific country requirements.
- Essential Document Review: Ensuring compliance by reviewing essential documents against regulatory checklists.
- Transactional Activities: Supporting tasks like Clinical Study Report (CSR) and Trial Master File oversight.
Qualifications and Skills
Candidates should possess the following:
- Educational Background: A Bachelor’s degree in healthcare or scientific fields is highly preferred. Equivalent experience will also be considered.
- Clinical Research Experience: A minimum of 1-2 years in clinical research, with at least 1 year in study start-up activities.
- Technical Proficiency: Competent use of Excel and familiarity with Vault Clinical or similar tracking systems.
- Document Review Expertise: Experience with ICF review, essential document assessment, and handling IRB/IEC and regulatory authority submissions.
Skills to Succeed
- Strong attention to detail for document review.
- Excellent organizational skills for tracking queries and managing surveys.
- Effective communication for liaising with regulatory bodies and affiliates.
- Adaptability in managing diverse transactional tasks in clinical study operations.
