Clinical Trial Specialist

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

Technical Competencies

• 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