Clinical Trial Specialist

Maze TherapeuticsSouth San Francisco, CA
4dHybrid

About The Position

At Maze Therapeutics, we’re on a mission to make a difference in the lives of people affected by common and rare diseases. If you’re looking for a role where you can be hands-on in the execution of global clinical trials and directly contribute to advancing treatments for patients, this could be the perfect opportunity for you. As a Clinical Trial Specialist, you’ll play a key role in supporting our Clinical Operations team as we deliver an exciting and diverse 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. This role will be supporting the MZE782 program for Chronic Kidney Disease. This position reports to the Senior Clinical Trial Manager.

Requirements

  • A strong clinical trial and/or industry background: Bachelor’s degree with 2+ years of experience in clinical trials – either at an academic institution or within a biotech/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.
  • Learning agility: Ability to rapidly acquire, apply, and adapt knowledge, skills, and insights in dynamic and unfamiliar situations.
  • Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs.as necessary, consistent with project needs.
  • 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.

Responsibilities

  • Driving Study Execution: Support the Clinical Operations Study Leads to oversee and monitor the conduct of our clinical studies, monitoring progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary.
  • Site & Vendor Oversight: Support site management oversight to ensure CRO activities align with the Monitoring Plan and facilitating protocol deviation discussions for quick resolution.
  • Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study 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: Develop study trackers and tools to best support study conduct and track study metrics and deliverables. Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed. Manage process for submitting and executing clinical contracts, as appropriate.
  • Sample & Data Management: Work with study team to coordinate sample shipments, sample analysis, and data reconciliation efforts.
  • 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.

Benefits

  • 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.
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