Intelliswift - An LTTS Company
Sr. Study Specialist, Global Study Operations
Intelliswift - An LTTS Company, San Rafael, California, United States, 94911
Sr. Study Specialist, Global Study Operations
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 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 Include But Are Not Limited To 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. We are an equal opportunities employer and welcome applications from all qualified candidates.
#J-18808-Ljbffr
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 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 Include But Are Not Limited To 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. We are an equal opportunities employer and welcome applications from all qualified candidates.
#J-18808-Ljbffr