Clinical documentation specialist [h1.location_city]

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 medicines. 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.

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 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.

What We’re Looking For

We’re looking for someone who’s not just checking the boxes but is truly passionate about bringing high quality clinical trials to life.  You might be a great fit if you have :

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease.  Maze is based in South San Francisco.

Our People

Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.

Our Core Values

Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.

Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.

Stand True – Our integrity is foundational; it guides us no matter the obstacle.

The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future.

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.

#LI-Hybrid

#LI-Hybrid