Sr. Clinical Trial Specialist

Position Summary

The Senior Clinical Trial Specialist (Sr. CTS) will support the Clinical Operations team in the execution of a global Phase 2 clinical trial in Phenylketonuria (PKU). This role partners closely with internal stakeholders, CROs, sites, and vendors to ensure studies are conducted efficiently, compliantly, and to the highest quality standards. The ideal candidate is organized, detail-oriented, proactive, and thrives in a fast-paced clinical development environment.

Key Responsibilities

Clinical Trial Execution

• Support oversight and execution of a global Phase 2 PKU study.
• Track study progress, identify trends or issues, and collaborate with Study Leads to implement corrective actions.

Site & Vendor Management

• Provide oversight of CRO site management activities, including report review, quality checks, trend analysis, and escalation of issues.
• Facilitate deviation discussions and support timely resolution of site-related challenges.
• Manage clinical trial vendors through study start-up, execution, and closeout, including day-to-day oversight and budget tracking.
• Hold vendors and CRAs accountable for deliverables, proactively identify risks, and recommend solutions.

Compliance & Documentation

• Ensure study activities comply with ICH-GCP guidelines, study protocols, and internal SOPs.
• Support Trial Master File (TMF) management, documentation oversight, metric tracking, and reconciliation activities.
• Assist in the development and review of key study documents, including protocols, informed consent forms (ICFs), amendments, and study materials.

Data, Samples & Study Coordination

• Coordinate sample shipment tracking, analysis activities, and data reconciliation efforts.
• Serve as a key point of contact for study-related inquiries and provide operational support to the Clinical Operations team.

Cross-Functional Collaboration & Process Improvement

• Participate in vendor meetings, drive resolution of study issues, and support continuous process improvement initiatives.
• Contribute to the development and enhancement of Clinical Operations SOPs and process documentation.

Qualifications

• Bachelor's degree with 2-3+ years of Clinical Operations experience within a biotech, pharmaceutical, or CRO environment.
• Strong understanding of clinical trial conduct and GCP/ICH guidelines.
• Experience with clinical trial systems such as Medidata Rave, Veeva, or similar platforms.
• Excellent organizational, problem-solving, and project management skills.
• Ability to manage multiple priorities and work effectively in a dynamic, fast-paced environment.
• Strong collaboration and communication skills with both internal and external stakeholders.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
• Willingness to travel approximately 10-15%, with additional travel as needed.

Work Location

Hybrid role requiring onsite presence in South San Francisco at least two days per week.