Study Specialist II, Global Study Operations

Job Title: Study Specialist II, Global Study Operations (GSO)

Location: UK (Hybrid)

Work Structure: Monday - Friday

Pay Rate: Available on request (inside IR35)

Study Specialist II, Global Study Operations (GSO) - The client:

The client is a global leader in developing therapeutics that provide significant advancements for patients with serious and life-threatening rare genetic diseases. They focus on diseases that often lack effective treatments and primarily affect children. The client is dedicated to improving the health and lives of people with rare diseases through innovative therapeutics, advancing standards of care, and providing personalized support and services worldwide.

Study Specialist II, Global Study Operations (GSO) - About the Role:

As a Study Specialist II in the Global Study Operations (GSO) team, you will play a crucial role in supporting and managing various aspects of clinical studies from Phase 1-4 and post-approval. You will contribute to the oversight of site monitoring, site management, and vendor management, ensuring the delivery of high-quality data to support the registration, approval, and ongoing monitoring of the client's clinical development assets.

Study Specialist II, Global Study Operations (GSO) - Key Responsibilities:

• Study Documentation: Develop and review study-specific documents as delegated by the Study Manager.
• Feasibility Assessment: Contribute to the management of country and site feasibility assessments.
• Regulatory Support: Manage regulatory document collection and tracking for participating sites.
• Training Materials: Contribute to the development of training materials for sites and investigators.
• Investigator Meetings: Present at investigator meetings as assigned.
• gov Updates: Ensure timely study entry and updates.
• Site Payments: Oversee investigator payments, including site setup, pass-through processing, and funding.
• Meeting Support: Provide administrative support for internal and external meetings.
• Site Management: Handle site-related issues and risks that cannot be resolved by CROs.
• Risk Management: Identify risks and implement mitigation strategies.
• Vendor Management: Support the Study Manager in vendor management tasks.
• Documentation Management: Oversee essential documents in the Trial Master File (TMF) and ensure proper filing in internal systems.

Education & Experience:

• Bachelor's degree or higher in nursing, life sciences, or health sciences preferred.
• Industry experience or relevant experience may be considered in lieu of formal education.
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors).