Senior Clinical Trial Specialist (PKU)
Maze Therapeutics
2 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Senior Clinical Trial Specialist (Sr. CTS)
Responsibilities:
- Partner with Clinical Operations to oversee and monitor a global Phase 2 PKU study; track progress, identify trends/issues, and implement corrective actions with Study Leads.
- Provide site management oversight (review reports, conduct QC checks, escalate trends to Global Site Manager); facilitate deviation discussions; identify site trends, training opportunities, and create tracking tools.
- Manage one or more clinical trial vendors from start to close-out, including day-to-day management and budget oversight; escalate to Study Lead as appropriate.
- Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
- Ensure clinical activities adhere to ICH/GCP, study plans/protocols, and Maze SOPs.
- Assist with study document design/development/review (protocols, informed consent forms, amendments, and other study materials).
- Attend vendor meetings; resolve study-related issues; drive continuous process improvement with CROs/external partners.
- Oversee Trial Master File (TMF) activities, including documentation and reconciliation/metric tracking.
- Coordinate and track sample shipments, analysis, and data reconciliation.
- Serve as a point of contact for study inquiries and provide organizational support to Clinical Operations.
- Contribute to creation/refinement of Clinical Operations SOPs and process documents.
Qualifications:
- Bachelor’s degree with 2–3+ years of Clinical Operations experience in biotech/pharma.
Skills/Requirements:
- Systematic, problem-solving mindset.
- Exceptional organizational skills and ability to manage multiple priorities.
- Proactive, collaborative approach and strong stakeholder relationships.
- Hands-on experience with clinical trial systems (e.g., Medidata Rave, Veeva, or similar).
- Flexibility in a fast-paced environment.
- Travel: up to 10–15%.
- Strong computer proficiency (Microsoft Office: Word, Excel, Outlook).
Work Schedule:
- Hybrid; onsite at South San Francisco headquarters at least two days per week.
Responsibilities:
- Partner with Clinical Operations to oversee and monitor a global Phase 2 PKU study; track progress, identify trends/issues, and implement corrective actions with Study Leads.
- Provide site management oversight (review reports, conduct QC checks, escalate trends to Global Site Manager); facilitate deviation discussions; identify site trends, training opportunities, and create tracking tools.
- Manage one or more clinical trial vendors from start to close-out, including day-to-day management and budget oversight; escalate to Study Lead as appropriate.
- Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
- Ensure clinical activities adhere to ICH/GCP, study plans/protocols, and Maze SOPs.
- Assist with study document design/development/review (protocols, informed consent forms, amendments, and other study materials).
- Attend vendor meetings; resolve study-related issues; drive continuous process improvement with CROs/external partners.
- Oversee Trial Master File (TMF) activities, including documentation and reconciliation/metric tracking.
- Coordinate and track sample shipments, analysis, and data reconciliation.
- Serve as a point of contact for study inquiries and provide organizational support to Clinical Operations.
- Contribute to creation/refinement of Clinical Operations SOPs and process documents.
Qualifications:
- Bachelor’s degree with 2–3+ years of Clinical Operations experience in biotech/pharma.
Skills/Requirements:
- Systematic, problem-solving mindset.
- Exceptional organizational skills and ability to manage multiple priorities.
- Proactive, collaborative approach and strong stakeholder relationships.
- Hands-on experience with clinical trial systems (e.g., Medidata Rave, Veeva, or similar).
- Flexibility in a fast-paced environment.
- Travel: up to 10–15%.
- Strong computer proficiency (Microsoft Office: Word, Excel, Outlook).
Work Schedule:
- Hybrid; onsite at South San Francisco headquarters at least two days per week.