Senior Clinical Trial Specialist, CKD

Position Overview

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 Specialist (Sr. CTS), you’ll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse Chronic Kidney Disease (CKD) pipeline of precision medicines. You’ll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies.

This role is ideal for someone who enjoys problem-solving, thrives in a fast‑paced environment, and is eager to take ownership of critical trial activities such as vendor and site management.

You’ll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include:

• Driving study execution:
  Partner with Clinical Operations to oversee and monitor the conduct of our global Phase 2 CKD study, track progress, identify trends or issues, and collaborate with Study Leads to implement corrective actions when necessary. Also help support early development studies in collaboration with the Study Lead.
• Site & vendor oversight:
  Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Study Lead) to ensure CRO activities align with study plans and protocols, and facilitate deviation discussions for quick resolution.
• Ensuring compliance & best practices:
  Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
• Supporting key study materials:
  Assist in the design and development of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
• Collaboration & leadership:
  Attend and contribute to vendor meetings, lead resolution of study‑related issues, and foster a culture of continuous process improvement with CROs and other external partners.
• Tracking & documentation:
  Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking, and reconciliation efforts as needed.
• Sample & data management:
  Coordinate sample shipments, sample analysis, and data reconciliation efforts with the study team.
• Cross‑functional collaboration:
  Serve as a point of contact for study‑related inquiries and provide high‑level administration, coordination, and organizational support to the Clinical Operations team.
• Process & SOP development:
  Contribute to creation and refinement of Clinical Operations SOPs to optimize study execution.

We’re looking for someone who’s not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have:

• A strong clinical operations background:
  Bachelor’s degree with 2‑3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.
• A systematic and problem‑solving mindset:
  You enjoy solving complex challenges and thinking critically to improve processes.
• Exceptional organizational skills:
  You can manage multiple priorities, stay detail‑oriented, and keep trials on track.
• A proactive and collaborative approach:
  You’re a strong team player who takes initiative and builds meaningful relationships with internal and external partners.
• Hands‑on experience with trial systems:
  Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.
• Flexibility and adaptability:
  You’re comfortable working in a fast‑paced, evolving environment and willing to roll‑up your sleeves to perform a broad range of clinical trial related tasks as needed.
• Willingness to travel:
  Up to 10‑15% travel, with the possibility of more based on project needs as necessary.
• Strong computer proficiency (Microsoft Office Suite – Word, Excel, Outlook).

This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week.

Maze Therapeutics is a clinical‑stage biopharmaceutical company harnessing the power of human genetics to…