Clinical Trial Manager, CKD South San Francisco, CA

Maze Therapeutics, Inc.; South San Francisco (CA); Hybrid; USD 143,000 - 175,000; Full time

Benefits offered by this job

Equity incentive plan

401(k) with employer match

Paid holidays and PTO

Job summary

Maze Therapeutics, based in South San Francisco, seeks a Clinical Trial Manager to drive CKD trials. You will manage CROs and investigators, oversee monitoring to ensure protocol compliance, and coordinate study materials.

The role collaborates across Clinical Operations and Science teams to engage with KOLs and investigators, traveling as needed. Ideal candidates have a scientific degree and 4+ years in clinical research, including 2+ years as CTM, with strong organizational and communication

Qualifications

• Degree in a scientific discipline or health-related field.
• Minimum of 4 years clinical research experience.
• At least 2 years as a Clinical Trial Manager in pharma or CRO.
• Experience in Phase I-II trials preferred.
• Knowledge of FDA regulations and ICH GCP.
• Strong organization and communication skills.
• Ability to multitask and build partner relationships.
• Willingness to travel as needed.

Responsibilities

• Manage external vendors including CROs and investigators.
• Oversee monitoring activities to ensure protocol and ICH GCP adherence.
• Coordinate study materials such as CRFs and ICFs.
• Serve as voice of Clinical Operations on cross-functional teams.
• Collaborate with Clinical Operations and Clinical Science on KOL engagement.

Skills

Vendor management

Clinical trial management

Regulatory knowledge

ICH GCP knowledge

Travel willing

MS Office Suite

Medidata Rave

Veeva

Project management

Education

Bachelor's degree in a scientific discipline or health-related field

Tools

Medidata Rave

Veeva

Microsoft Office

Project

Excel

Job description

### The Position### The Impact You’ll Have* Manage external vendors including CROs, additional key vendors, and global investigative sites.* Ensure adherence to study protocols, SOPs, ICH GCP guidelines by overseeing monitoring activities at investigative sites.* Coordinate the development of study materials such as CRFs, ICFs, patient diaries.* Act as the voice of Clinical Operations on cross-functional teams, including the Study Execution Team (SET).* Partner with Clinical Operations and Clinical Science Team to engage with therapeutic area KOLs and Investigators.### What We’re Looking For* A degree in a scientific discipline or health related field.* Minimum of 4 years clinical research experience, including 2 years as a Clinical Trial Manager at a biopharmaceutical company or CRO.* Experience with planning and executing Phase I-II trials is preferred.* Demonstrated proficiency in implementing, monitoring, and management of clinical trials, from start-up to close-out.* General knowledge of FDA regulatory requirements and ICH GCP guidelines.* Strong organizational skills, ability to prioritize and multi-task.* Excellent verbal and written communication skills.* Demonstrated problem-solving and negotiation abilities.* Ability to work as part of a team and build strong working relationships with internal and external partners.* Capacity to roll-up sleeves to perform a broad range of clinical trial related tasks as needed.* Willingness to travel as necessary, consistent with project needs.* Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook).* Experience with clinical trial databases (e.g., Medidata Rave, Veeva, etc.).### ### **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 $143,000 - $175,000. 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*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 **Clinical Trial Manager (CTM)** at Maze Therapeutics, you’ll play a hands-on role in co-leading and 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. - Steer the execution of one or more of our Phase 2 CKD clinical trials; from protocol development to achievement of corporate and study milestones such as first patient in, interim analysis, database lock, and study report completion.---EducationSelect...Select...Select...If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.