Clinical Project Manager - Pleasanton, CA

About this role

<div class="content-intro"><p>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.</p> <p>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.</p></div><p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Summary:</span><span data-ccp-parastyle="Normal (Web)"> </span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <p><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">The Clinical </span><span data-ccp-parastyle="Normal (Web)">Project</span><span data-ccp-parastyle="Normal (Web)"> </span><span data-ccp-parastyle="Normal (Web)">Manager </span><span data-ccp-parastyle="Normal (Web)">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. Th</span><span data-ccp-parastyle="Normal (Web)">is position</span><span data-ccp-parastyle="Normal (Web)"> 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. </span></span><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <p><strong><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">In This Role, You Will</span><span data-ccp-parastyle="Normal (Web)">:</span></span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"335557856":16777215}"> </span></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Normal (Web)">Ability to effectively </span><span data-ccp-parastyle="Normal (Web)">manage clinical</span><span data-ccp-parastyle="Normal (Web)"> studies to support the clinical operation goals that align with the company’s visions for evidence generation</span></span><span data-ccp-props="{"134233117":false,"134233118":false,"335557856":16777215,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Ensure clinical research is conducted in accordance with 21 CFR Part 812, 50 and 56 and applicable international standards (ISO 14155:2026)</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Identify, evaluate and qualify clinical sites to ensure compliance with applicable regulatory regulations</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Assist in negotiating clinical site budgets and study contracts</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Prepare clinical monitoring guidelines</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Generate various study and training materials to support clinical trials</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Source, manage and train contract CRAs assigned to study sites</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Review and approve CRA monitoring trip reports</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> <li><span data-contrast="auto">Conduct site initiation visits and monitoring visits, and provide clinical trial related training for RCs, Investigators, OR staff, etc.</span><span…