Clinical Trial Specialist
GForce Life Sciences, San Rafael, CA, United States
Senior Study Specialist, Global Study Operations
6-month Contract
Hybrid in San Rafael, CA
Key Responsibilities
Support development of study-specific documentation and operational plans
Contribute to country and site feasibility assessments and site selection activities
Oversee CRO activities related to IRB/EC submissions and approvals
Manage essential study documents across the full study lifecycle
Support development and delivery of site and investigator training materials
Present at investigator meetings, as needed
Ensure accuracy and timeliness of study-related documentation and tracking
Oversee clinical trial insurance processes
Participate in cross-functional study execution, vendor, and internal team meetings
Manage study postings and updates on clinical trial registries (e.g., ClinicalTrials.gov)
Facilitate and track study-related documentation (e.g., screening authorizations, signatures)
Identify operational risks and contribute to mitigation strategies
Provide operational and administrative support for internal and external meetings
Study Operations & Execution
Maintain end-to-end understanding of clinical trial operations, including start-up, maintenance, and close-out
Understand clinical trial lifecycle milestones, critical path dependencies, and inspection readiness expectations
Independently manage complex operational workstreams with minimal oversight in a fast-paced environment
Systems & Tools
Experience with clinical systems, including:
TMF/eTMF systems (ensuring quality, completeness, and inspection readiness)
EDC systems (understanding operational interfaces and timelines)
IRT/IXRS and eCOA/ePRO platforms, as applicable
Track vendor milestones, site performance, and KPIs
Utilize collaboration tools such as Microsoft Teams and SharePoint
Maintain high standards for system accuracy, reconciliation, and data integrity
Core Competencies
Agility and proactivity
Strong communication and collaboration skills
Leadership and ability to influence cross-functional teams
Clinical study management and execution
Compliance, quality, and regulatory awareness
Understanding of drug development and study design
Therapeutic area knowledge
Qualifications
Bachelor’s degree in life sciences, health sciences, or related field preferred (or equivalent experience)
Experience within a biotechnology, pharmaceutical, or clinical research environment
Prior experience managing external vendors (e.g., CROs, central labs, imaging vendors), including scope, budgets, and invoices
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6-month Contract
Hybrid in San Rafael, CA
Key Responsibilities
Support development of study-specific documentation and operational plans
Contribute to country and site feasibility assessments and site selection activities
Oversee CRO activities related to IRB/EC submissions and approvals
Manage essential study documents across the full study lifecycle
Support development and delivery of site and investigator training materials
Present at investigator meetings, as needed
Ensure accuracy and timeliness of study-related documentation and tracking
Oversee clinical trial insurance processes
Participate in cross-functional study execution, vendor, and internal team meetings
Manage study postings and updates on clinical trial registries (e.g., ClinicalTrials.gov)
Facilitate and track study-related documentation (e.g., screening authorizations, signatures)
Identify operational risks and contribute to mitigation strategies
Provide operational and administrative support for internal and external meetings
Study Operations & Execution
Maintain end-to-end understanding of clinical trial operations, including start-up, maintenance, and close-out
Understand clinical trial lifecycle milestones, critical path dependencies, and inspection readiness expectations
Independently manage complex operational workstreams with minimal oversight in a fast-paced environment
Systems & Tools
Experience with clinical systems, including:
TMF/eTMF systems (ensuring quality, completeness, and inspection readiness)
EDC systems (understanding operational interfaces and timelines)
IRT/IXRS and eCOA/ePRO platforms, as applicable
Track vendor milestones, site performance, and KPIs
Utilize collaboration tools such as Microsoft Teams and SharePoint
Maintain high standards for system accuracy, reconciliation, and data integrity
Core Competencies
Agility and proactivity
Strong communication and collaboration skills
Leadership and ability to influence cross-functional teams
Clinical study management and execution
Compliance, quality, and regulatory awareness
Understanding of drug development and study design
Therapeutic area knowledge
Qualifications
Bachelor’s degree in life sciences, health sciences, or related field preferred (or equivalent experience)
Experience within a biotechnology, pharmaceutical, or clinical research environment
Prior experience managing external vendors (e.g., CROs, central labs, imaging vendors), including scope, budgets, and invoices
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