Sr. Study Specialist

W2 Contract

Salary Range: $104,000 - $124,800 per year

Location: Novato, CA - Hybrid Role

Job Summary:

The Sr. Study Specialist significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study-related matters that impact study participant safety, data integrity, study timelines, quality, and budget. You will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Duties and 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.
• 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.) Global Experience

Requirements and Qualifications: 

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

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. 

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