Sr Study Specialist

Responsibilities

• Develop study specific documentation, as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection
• Oversight of CRO for IRB/EC related submission/approval activities
• Oversee essential documents for study life-cycle management
• Develop/Oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely Oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s)
• Oversee and manage study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• Process documents for signature in DocuSign
• Contribute to Global Study Operations risks identification and mitigations
• Provide support and administrative assistance with internal and external meetings

Qualifications

• BA/BS or higher in nursing, life or health sciences is preferred
• Industry or relevant experience in lieu of education is considered
• Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)