Site Start up Specialist
Primary Location: India, Hyderabad Job ID R0000043661 Category Clinical Trials
About this Role
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 strong 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 comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.
- Tracks document status, collects study metrics, and provides updates to study teams and stakeholders.
- Works with and provides status to study team to ensure essential documentation packages are approved for initial drug shipments according to study timelines. Supports Clinical Study team in ensuring regulatory documents are submission and audit ready Escalates as necessary.
Job Requirement:
- Ability to manage and oversee essential regulatory documents, including collection, review, and TMF filing
- Good communccation and interpersonal skills for routine updates and reports
- Attention to detail for the ability to ensure accuracy, quality, and inspection readiness of documentation
- Organizational and time management skills, including prioritization and ability to meet tight timelines and competing deadlines
- Ability to work proactively and independently, demonstrating self-discipline and ownership of deliverables
- Ability to acquire working knowledge in trial management systems and proficiency in Microsoft Office tools (Excel, PowerPoint, Word, Project).
- Basic familiarity with medical terms and clinical drug development preferred
Minimum Years of Experience:
- Bachelor’s degree and minimum of 1-2 years of relevant industry experience
- Advanced Degree can be considered in lieu of years
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