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Senior Clinical Trial Specialist

2-3 years
$126,000 to $154,000
10 March 21, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Trial Specialist
Company: Maze Therapeutics
Location: South San Francisco, CA, USA (Hybrid Schedule: Onsite 2 days/week)
Employment Type: Other
Benefits Offered: Medical, Dental, Vision, Paid Time Off, Retirement

The Position:

As a Senior Clinical Trial Specialist at Maze Therapeutics, you will play a pivotal role in supporting the Clinical Operations team by ensuring the smooth execution of clinical studies. This position involves close collaboration with internal teams, CROs, and vendors to deliver an exciting pipeline of precision medicines. You’ll report directly to the Director of Clinical Operations and work cross-functionally to advance therapies for patients in need.

The Impact You'll Have:

You’ll be an essential part of the clinical team, ensuring high-quality trial execution with precision and efficiency. Key contributions include:

  • Study Execution: Partner with the Clinical Operations Study Lead to oversee and monitor the conduct of global Phase 2 CKD studies, identifying trends, resolving issues, and implementing corrective actions.

  • Site & Vendor Oversight: Lead site management oversight, ensuring CRO activities align with the Monitoring Plan and facilitating prompt resolution of protocol deviations.

  • Compliance & Best Practices: Ensure adherence to ICH/GCP Guidelines, study protocols, and Maze SOPs.

  • Study Materials Development: Assist in designing and developing study documents, including protocols, informed consent forms (ICFs), amendments, and study materials.

  • Collaboration & Leadership: Contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous improvement.

  • Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring accurate documentation, metric tracking, and reconciliation.

  • Sample & Data Management: Coordinate sample shipments, sample analysis, and data reconciliation.

  • Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administrative and organizational support.

  • Process & SOP Development: Contribute to the refinement of Clinical Operations SOPs to optimize study execution.

What We're Looking For:

We’re looking for someone who is passionate about bringing high-quality clinical trials to life. Ideal candidates will have:

  • Clinical Operations Background:

    • Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.

  • Problem-Solving Mindset: Ability to solve complex challenges and improve processes.

  • Organizational Excellence: Strong ability to manage multiple priorities while maintaining attention to detail.

  • Proactive & Collaborative Approach: Strong team player who takes initiative and builds relationships with internal and external partners.

  • Trial Systems Experience: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms.

  • Flexibility & Adaptability: Comfortable working in a fast-paced, evolving environment and willing to perform a broad range of trial-related tasks.

  • Travel Requirement: Willingness to travel up to 10-15%, with the potential for more based on project needs.

  • Technical Proficiency: Strong skills in Microsoft Office Suite (Word, Excel, Outlook).

About Maze Therapeutics:

Maze Therapeutics is a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, cardiovascular, and related metabolic diseases. Leveraging its Compass platform, Maze identifies and characterizes genetic variants in disease and links those variants to biological pathways driving disease progression.

Core Values:

  • Further Together: Resilience and teamwork drive our mission.

  • Impact Obsessed: We take bold, calculated risks to improve lives.

  • Stand True: Integrity guides us in overcoming challenges.

Compensation & Benefits:

  • Salary Range: $126,000 - $154,000 annually

  • Performance Bonus: Annual performance-based bonus

  • Comprehensive Benefits: Medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match, generous holiday and PTO policy