Study Specialist

Key Responsibilities

• Develop study-specific documentation as delegated by the Study Manager
• Contribute to country and site feasibility assessment and site selection
• Oversee CRO activities related to IRB/EC submissions and approvals
• Manage essential documents across the study lifecycle
• Develop and/or oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely updates to ClinicalTrials.gov
• Facilitate and track Screening Authorization Forms, where applicable
• Process documents for signature via DocuSign
• Oversee Clinical Trial Insurance activities
• Represent the Global Study Operations (GSO) team in cross-functional meetings and take meeting minutes as needed
• Manage essential documents within the Trial Master File (TMF)
• Support identification and mitigation of Global Study Operations risks
• Provide administrative support for internal and external meetings

Requirements

• BA/BS or higher in nursing, life sciences, or health sciences preferred (relevant industry experience may substitute)
• Experience in biotechnology or pharmaceutical industry
• Proven oversight of external vendors (e.g., CROs, central labs, imaging), including management of Statements of Work (SOW), budgets, purchase orders (POs), and invoices

If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at or call: (0)