Clinical Project Manager - Pleasanton, CA

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. It 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 hands‑on role is ideal for candidates who thrive in dynamic settings and have a passion for operational excellence in clinical research. In This Role, You Will Effectively manage clinical studies to support the company’s evidence generation goals. Ensure research complies with 21 CFR Part 812, 50 and 56 and applicable international standards (ISO 14155). Identify, evaluate, and qualify clinical sites to ensure regulatory compliance. Assist in negotiating clinical site budgets and study contracts. Prepare clinical monitoring guidelines and generate study and training materials. Source, manage, and train contract CRAs assigned to study sites. Review and approve CRA monitoring trip reports. Conduct site initiation and monitoring visits, providing trial‑related training for RCs, investigators, and OR staff. Provide surgical technique training and proctor clinical cases at hospital and ASC facilities. Plan and conduct investigator meetings. Identify, evaluate, and manage CROs or vendors for data management, statistics, and monitoring. Provide technical eDC and clinical support during research. Monitor study data and assist with cleaning eDC and other databases. Develop project management tools, tracking tools, metrics, and report to management. Conduct and summarize literature reviews to support clinical activities. Coordinate data analysis and prepare clinical reports for regulatory filings. Assist with development of clinical strategy, including protocols and investigational plans. Other duties may be assigned as part of the job scope. Who You Will Report To Sr. Director, Clinical Operations Requirements Degree 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 work cross‑functionally and manage multiple tasks. Ability to prioritize projects and display initiative and flexibility. Detail oriented with strong people and organizational skills. Strong medical background and understanding of clinical research fundamentals 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 50% of the time. Proficiency in PowerPoint, Excel and eDC platforms. Compliance with relevant county, state, and Federal rules regarding vaccinations. What We Offer At Calyxo, you will be part of a knowledgeable, high‑achieving, experienced, and fun team in a diverse work environment with proven leaders. You will experience constant learning and dynamic challenges to help you grow and become the best version of yourself. We Also Offer An Attractive Compensation Package, Which Includes A competitive base salary range of $140,000 – $150,000 and variable incentive plan. Stock options – ownership and a stake in a growing 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. Diverse viewpoints 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 and to complete the required employment eligibility verification form upon hire. #J-18808-Ljbffr