Senior Clinical Trial Manager, CKD

Role Summary

Senior Clinical Trial Manager (Sr. CTM) at Maze Therapeutics, driving CKD clinical trials with a hands-on role in mid-to-late-stage studies. You’ll work cross-functionally with internal teams and external partners to ensure trials run efficiently and with high quality standards. If you enjoy rolling up your sleeves and bringing innovative medicines to patients, this role could be a perfect fit.

Responsibilities

• Clinical Trial Execution & Leadership
  • 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 protocol development to key milestones (FPI, enrollment completion, interim analysis, database lock, final CSR).
  • Drive study feasibility to inform site selection strategy and enrollment forecasts.
  • Partner with Clinical Science to engage with therapeutic area KOLs.
• Vendor, CRO & Site Management
  • Lead RFP processes from CROs and vendors through final vendor selection, including budget and contract negotiations.
  • Oversee CRO and vendor onboarding and day-to-day oversight, ensuring adherence to budgets, protocols, and ICH-GCP guidelines.
• Budget & Financial Oversight
  • Support study-specific budget tracking and vendor spend management.
• Data Quality, Compliance & Regulatory Readiness
  • 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.
• Process Optimization & Technology Implementation
  • Evaluate and implement clinical trial systems (e.g., eTMF, CTMS, RBM) to enhance efficiency.
  • Assist in developing SOPs and scalable processes for clinical operations.
• Cross-functional Collaboration
  • Partner with internal teams, such as CMC and Clinical Supply Chain, to manage study drug supply and distribution; work with other functions to ensure smooth study execution.

Qualifications

• 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.
• Experience in common disease drug development preferred.
• Familiarity with regulatory guidelines (FDA, EMA, ICH-GCP).
• Experience conducting a broad range of clinical trial activities including start-up to close-out, clinical trial databases (e.g., Medidata RAVE, Veeva), knowledge of 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.

Skills

• Clinical trial operations management
• Cross-functional collaboration and stakeholder management
• Excellent written and verbal communication

Additional Requirements

• Travel up to 30% to support study needs.