Sr. Study Specialist, Global Study Operations

Intelliswift Software • Santa Clara, CA

81d

About The Position

The Client Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

Requirements

• 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.)

Nice To Haves

• BA/BS or higher in nursing, life or health sciences is preferred
• Industry or relevant experience in lieu of education is considered

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
• Oversight of essential documents for study life-cycle management
• Develop/Oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• Process documents for signature in DocuSign
• Oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
• Oversee and manage essential documents in the Trial Master File (TMF)
• Contribute to Global Study Operations risks identification and mitigations.
• Provide support and administrative assistance with internal and external meetings

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree