Senior Clinical Trial Specialist (PKU)

Maze Therapeutics•South San Francisco, CA

11h•$125,000 - $152,000•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 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.

Requirements

Bachelor’s degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.
A systematic and problem-solving mindset.
Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track.
A proactive and collaborative approach.
Hands-on experience with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.
Flexibility and adaptability: You thrive 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

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.
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.
Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
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.
Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed.
Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts.
Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team.
Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution.