GForce Life Sciences
Executive Recruiter at GForce Life Sciences
Clinical Study Operations
12-month contract
Hybrid - San Rafael, CA
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:
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
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 mitigation.
Provide support and administrative assistance with internal and external meetings
Education & Experience
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
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Seniority level Mid-Senior level
Employment type Contract
Job function Research
Industries Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
Referrals increase your chances of interviewing at GForce Life Sciences by 2x
#J-18808-Ljbffr
12-month contract
Hybrid - San Rafael, CA
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:
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
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 mitigation.
Provide support and administrative assistance with internal and external meetings
Education & Experience
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
Core Competencies
Agility and Proactivity
Leadership
Communication and Collaboration
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Seniority level Mid-Senior level
Employment type Contract
Job function Research
Industries Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Medical insurance
Vision insurance
401(k)
Referrals increase your chances of interviewing at GForce Life Sciences by 2x
#J-18808-Ljbffr