Clinical Project Manager - Pleasanton, CA

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. Th is 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.   Provide surgical technique training and proctor clinical cases at hospital and ASC facilities   Plan and conduct investigator meetings   Assist in identifying, evaluating and managing CROs or vendors for study related services including but limited to: data management, statistical analysis, monitoring   Provide technical eDC and clinical support during clinical research   Monitor clinical study data and assist in cleaning of eDC and other study databases   Develop project management tools to manage clinical projects   Develop study tracking tools and metrics and report to management   Conduct and summarize literature reviews in support of clinical activities   Assist with coordination of data analysis and prepare clinical reports to support regulatory filings   Assist with development of clinical strategy, which includes the preparation of clinical protocols and investigational plans.   Other duties may be assigned as a part of job scope   Who You Will Report To:   Sr. Director, Clinical Operations Requirements:   D egree in a life science  (BS or MS)   7 +  years of relevant clinical experience in medical devices  (or a combination of pharma and med devices)      At least  four   years of full-cycle clinical project management experience.   Intimate working knowledge of US clinical research and medical device regulations.    Ability to effectively work cross-functionally with multiple departments; manage completion of multiple tasks .     Ability to prioritize projects and display  initiative  and flexibility .     Detail oriented, strong people and organizational skills.    Strong medical background and understanding of the fundamentals of clinical research and statistical methodology .   Background in urology research  preferable .    Proficient with PC and associated software. Strong technical,  written  and communication skills.   Ability to travel up to  5 0% of the time   Proficiency in Power Point, Excel and eDC platforms   Compliance with relevant county, state, and Federal rules regarding vaccinations.     What  W e  O ffer :     At  Calyxo , you will be part of a knowledgeable, high-achieving,  experienced  and fun team .   You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture .   You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself .       We also offer  an attractive  compensation package, which includes :   A c ompetitive  base  salary range of $140,000 - $150,000  and variable incentive plan     Stock options – ownership and a stake in growing a  mission-driven company   Employee benefits package that includes 401(k), healthcare insurance and paid vacation   Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only  valued but also  prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.     Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States an