Job Overview: The role involves collaborating with the strategic Clinical Study Start-Up (CSS) team to create and distribute various documents and system builds, facilitating efficient global study start-up activities.
Key Responsibilities:
- Survey Build: Develop electronic surveys listing key study documents based on study requirements.
- Package Build: Prepare electronic packages for sites, including essential and regulatory documents.
- Query Tracking: Monitor queries from regulatory bodies within the electronic system.
- Informed Consent Form (ICF) Build: Create ICF templates adhering to country-specific requirements.
- Essential Document Review: Assess essential documents against checklists per country regulations.
- Additional Activities: Participate in tasks such as Clinical Study Report (CSR) preparation and Trial Master File Oversight.
Qualifications:
- Education: Bachelor’s degree in healthcare or a scientific field is highly preferred; equivalent experience is acceptable.
- Experience:
- 1-2 years in clinical research.
- At least 1 year in study start-up.
- Proficiency in ICF review and essential document assessment.
- Experience with IRB/IEC and competent authority submissions and approvals.
- Familiarity with Vault Clinical or similar tracking systems.
- Skills: Competent in using Excel.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company focuses on accelerating the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.