Clinical Trial Specialist

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 clinical trial in the rare disease, Phenylketonuria (PKU). You’ll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate 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.

The Impact You’ll Have

You’ll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include:

• Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary.
• Site, Vendor Management & Oversight:
  • Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Global Site Manager) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight.
  • Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as, appropriate.
  • Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
• 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, development, and review 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.