When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 solid 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.
- Overse

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