Clinical Trial Manager, CKDSouth San Francisco, CA

About the role

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.

Responsibilities

• 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.
• 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.
• Care for 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.

Requirements

• 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.).

Qualifications

• 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.).

Skills

• Strong organizational skills.
• 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.).

Benefits

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

Pay

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.

Schedule

Full time.