- Global Site Initiation: Manage and coordinate documentation for global site initiation processes.
- Study Start-Up Documentation: Prepare and oversee documentation for global study start-up, including protocols and Informed Consent Forms (ICFs).
- NDA/CDA and CTA Dossiers: Handle the preparation and coordination of New Drug Applications (NDA), Confidential Disclosure Agreements (CDA), and Clinical Trial Application (CTA) dossiers.
- Clinical Trial Management System (CTMS): Maintain and manage data within the CTMS to ensure compliance and accuracy.
Required Skills:
- Extensive experience in global site initiation and study start-up documentation.
- Proficiency in preparing protocols, ICFs, NDA/CDA, and CTA dossiers.
- Familiarity with Clinical Trial Management Systems (CTMS).
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
Experience:
- 3 to 7 years of relevant industry experience in document coordination and management within clinical trials.
Location:
- Hyderabad (Hybrid model with 2-3 days onsite per week)
How to Apply:
If you meet the qualifications and are interested in this opportunity, please send your updated resume to pooja.bombrade@iqvia.com.