The Specialist, Global Site Start-up, is responsible for executing core site start-up activities for clinical trials, supporting the collection, review, tracking, and submission of regulatory and investigator site documentation to enable timely site activation. Works collaboratively with internal teams and CRO partners to ensure documentation completeness, accuracy, and compliance with Regeneron SOPs, ICH-GCP, and country-specific requirements. Maintains a robust focus on operational execution, data accuracy, and inspection readiness, while proactively identifying and resolving document-related issues to support study timelines.

Key Accountabilities:

Site Initiation and Regulatory Packages
- Support regulatory submissions as needed, including activities such as: providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc.




- Distributes complete document packages to sites in a structured and time-sensitive manner.
- Tracks documents requiring translation and coordinates with vendors to manage scope and timelines.
- Perform due diligence checks

Study Investigator Site Essential Document Oversight
- Executes standardized processes for collection, review, and tracking of investigator site essential documents.
- Oversee the preparation and approval of site regulatory package, ensuring compliance with country-specific requirements, TMF standards, and ICH-GCP guidelines, while supporting inspection readiness and maintaining high-quality site documentation.
- Reviews document packages from CROs per process and escalates issues as needed.
- May coordinate with CROs to support document collection and IRB timelines for site activation.
- Ensures timely and accurate upload of essential documents into the eTMF, resolving all document quality issues.
- Ensure compr

📌 Site Start up Specialist (Hyderabad)
🏢 Parexel
📍 Hyderabad