INTELLISWIFT INC
Sr. Study Specialist, Global Study Operations
INTELLISWIFT INC, San Rafael, California, United States, 94911
Overview
Job Title: Sr. Study Specialist, Global Study Operations Duration: 1 Year Location: San Rafael, CA Hybrid – 2 Days/Week
Role Summary
The Sr. Study Specialist (SS) 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. The Sr. SS 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). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies:
Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge
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
Skills
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.).
Education BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
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Job Title: Sr. Study Specialist, Global Study Operations Duration: 1 Year Location: San Rafael, CA Hybrid – 2 Days/Week
Role Summary
The Sr. Study Specialist (SS) 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. The Sr. SS 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). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies:
Study Management and Execution, Compliance and Quality, Drug Development and Study Design, Product and Therapeutic Area Knowledge
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
Skills
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.).
Education BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
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