Senior Clinical Trial Manager, CKD jobs in United States
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Maze Therapeutics · 2 weeks ago

Senior Clinical Trial Manager, CKD

Maze Therapeutics is a clinical-stage biopharmaceutical company focused on precision medicine for patients with renal and related diseases. As a Senior Clinical Trial Manager, you will lead the execution of Chronic Kidney Disease clinical trials, ensuring high-quality standards and collaboration across teams and vendors.

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H1B Sponsor Likelynote

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

Qualification

Clinical Trial ManagementRegulatory Guidelines FamiliarityVendor ManagementBudget TrackingClinical Trial DatabasesCross-functional CollaborationStartup MindsetProblem-solving SkillsCommunication Skills

Required

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
Global trial experience is a plus
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

Preferred

Experience in common disease drug development preferred

Benefits

Competitive medical, dental, and vision insurance
Mental health offerings
Equity incentive plan
401(k) program with employer match
Generous holiday and PTO policy

Company

Maze Therapeutics

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Maze Therapeutics is a biotechnology company that develops precision medicines for renal, cardiovascular, and metabolic diseases.

H1B Sponsorship

Maze Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (5)
2021 (3)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$646M
Key Investors
Matrix Capital ManagementCity Hill Ventures
2025-09-11Post Ipo Equity· $150M
2025-01-31IPO
2024-12-03Series D· $115M

Leadership Team

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Jason Coloma
Chief Executive Officer
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Misbah Tahir
Chief Financial Officer
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Company data provided by crunchbase