Clinical Project Manager - Pleasanton, CA

About this role

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The Clinical Project Manager plays a critical role in leading the execution of clinical trials from start to finish. This position ensures trials are conducted efficiently, on time, and in full compliance with regulatory requirements. This position collaborates closely with internal stakeholders and external partners—including CRAs, CROs, and clinical sites—to generate high-quality clinical evidence that informs product development and regulatory strategy. This is a hands-on role within a fast-paced, team-driven environment, ideal for candidates who thrive in dynamic settings and have a passion for operational excellence in clinical research.

In This Role, You Will:

• Ability to effectively manage clinical studies to support the clinical operation goals that align with the company’s visions for evidence generation

• Ensure clinical research is conducted in accordance with 21 CFR Part 812, 50 and 56 and applicable international standards (ISO 14155:2026)

• Identify, evaluate and qualify clinical sites to ensure compliance with applicable regulatory regulations

• Assist in negotiating clinical site budgets and study contracts

• Prepare clinical monitoring guidelines

• Generate various study and training materials to support clinical trials

• Source, manage and train contract CRAs assigned to study sites

• Review and approve CRA monitoring trip reports

• Conduct site initiation visits and monitoring visits, and provide clinical trial related training for RCs, Investigators, OR staff, etc.