Senior Clinical Trial Specialist, CKD

Maze Therapeutics • South San Francisco, CA

1d • Hybrid

About The Position

At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you’ll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse Chronic Kidney Disease (CKD) pipeline of precision medicine s . You’ll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies . This role is ideal for someone who enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management.

Requirements

• A strong clinical operations background : Bachelor’s degree with 2- 3 + years of experience in Clinical Operations within a biotech or pharmaceutical environment.
• A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes.
• Exceptional organizational skills: Y ou can manage multiple priorities , staying detail-oriented, and keep trials on track .
• A proactiv e and collaborative approach : You’re a strong team player who takes initiative and builds meaningful relationships with internal and external partners .
• Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.
• Flexibility and adaptability: You’re comfortable working in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed.
• Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary.
• Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook).

Responsibilities

• Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 CKD study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary. Will also help support Early Development studies in collaboration with Study Lead.
• Site & Vendor Oversight: Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Study Lead) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution.
• Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
• Supporting Key Study Materials: Assist in the design and development of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
• Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners.
• Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed.
• Sample & Data Management: Work with study team to coordinate sample shipments, sample analysis, and data reconciliation efforts.
• Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team.
• Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) to optimize study execution.

Benefits

• Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees