Senior Clinical Trial Manager, CKD

Maze Therapeutics•South San Francisco, CA

12h•$176,000 - $215,000•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 Manager (Sr. CTM) at Maze Therapeutics, you’ll play a hands-on role in driving the execution of our Chronic Kidney Disease (CKD) clinical trials. You’ll have the opportunity to contribute to mid to late-stage clinical studies, work cross-functionally with internal teams and external partners, and ensure trials run efficiently and with the highest quality standards. If you enjoy rolling up your sleeves, collaborating across teams, and bringing innovative medicines to patients, this role could be the perfect fit for you.

Requirements

A Bachelor’s degree in a scientific discipline or health related field with 5–8 years of clinical operations experience, including at least 4 years as a CTM, with hands-on experience managing Phases II–III clinical trials.
Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP)
Experience conducting a broad range of clinical trial related activities including study start-up to study close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of clinical trial budgeting, and managing CROs and vendors.
Strong executional leadership, problem-solving skills, and ability to manage cross-functional teams at the study level.
A startup mindset, willingness to roll up sleeves, and ability to work in a fast-paced, evolving, and collaborative team environment.
Excellent communication skills and the ability to manage cross-functional relationships effectively.
Are willing to travel up to 30% to support study needs.

Nice To Haves

Global trial experience is a plus.
Experience in common disease drug development preferred.

Responsibilities

Co-lead a mid-stage Phase II clinical trial in Chronic Kidney Disease, ensuring high-quality execution from study design to completion.
Contribute to the Study Execution Team (SET), from study design and protocol development to completion of key study milestones (FPI, enrollment completion, interim analysis, database lock, and final CSR).
Drive study feasibility efforts to inform site selection strategy to ensure timely study enrollment and completion; develop study enrollment forecasts.
Partner with Clinical Science to engage with therapeutic area KOLs.
Lead and facilitate request for proposals from CROs and clinical trial vendors through final vendor selection as well as budget and contract negotiations
Oversee CRO and vendor onboarding, and day-to-day oversight, ensuring adherence to budgets, protocols, and ICH-GCP guidelines.
Support Clinical Operations Leadership with study-specific budget tracking and vendor spend management.
Ensure clinical trial data integrity and adherence to protocols, SOPs, and ICH-GCP guidelines through oversight of CROs, vendors, and site monitoring activities.
Partner with Quality Assurance on inspection readiness efforts.
Contribute to evaluating and implementing clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency.
Assist in developing SOPs and scalable processes for clinical operations.
Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution.
Work closely with other functions to ensure smooth study execution.