Clinical Project Manager - Pleasanton, Ca

Calyxo, Inc.

Pleasanton, CA, United States
On-site
Manage clinical studies from start to finish
Ensure compliance with 21 cfr part 812, 50, and 56
Qualify clinical sites and negotiate budgets
Calyxo, Inc. is seeking a Clinical Project Manager in Pleasanton, CA, to lead clinical trials for innovative kidney stone treatment solutions. The ideal candidate should have experience in managing clinical studies, ensuring compliance with regulatory standards, and collaborating with various stakeholders

Job Summary

  • The Clinical Project Manager plays a critical role in leading the execution of clinical trials from start to finish while ensuring full regulatory compliance.
  • This position involves collaborating closely with external partners including CRAs, CROs, and clinical sites to generate high-quality clinical evidence.
  • Candidates must be ready to change the future of kidney stone treatment within a dynamic team working in a fun, diverse atmosphere.

Matching Summary

Match Score: 85

Calyxo, Inc. is seeking a Clinical Project Manager in Pleasanton, CA, to lead clinical trials for innovative kidney stone treatment solutions. The ideal candidate should have experience in managing clinical studies, ensuring compliance with regulatory standards, and collaborating with various stakeholders.

Skills & Requirements

Must-have

  • Manage clinical studies from start to finish
  • Ensure compliance with 21 CFR Part 812, 50, and 56
  • Qualify clinical sites and negotiate budgets
  • Source and train contract CRAs
  • Conduct site initiation and monitoring visits
  • Provide surgical technique training and proctoring
  • Develop project management tools and metrics

Nice-to-have

  • Passion for operational excellence in clinical research
  • Ability to thrive in fast-paced team-driven environment
  • Experience with international standards ISO 14155:2026
  • Strong collaboration skills with internal stakeholders

Key Requirements

  • Knowledge of 21 CFR Part 812, 50, and 56
  • Experience with ISO 14155:2026 international standards
  • Background in medical device clinical operations
  • Surgical technique training and proctoring experience

Work Rights

Not specified

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