Clinical Project Manager - Pleasanton, CA

Calyxo • Pleasanton, CA

16h • Onsite

About The Position

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, founded in 2016 to address the significant need for improved kidney stone treatment. The company's team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices in urology. The Clinical Project Manager plays a critical role in leading the execution of clinical trials from start to finish, ensuring trials are conducted efficiently, on time, and in full compliance with regulatory requirements. This position involves close collaboration 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.

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 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.
• Proficient with PC and associated software.
• Strong technical, written and communication skills.
• Ability to travel up to 50% of the time
• Proficiency in Power Point, Excel and eDC platforms
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Nice To Haves

• Background in urology research

Responsibilities

• 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

Benefits

• A competitive 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
• Constant learning and dynamic challenges to help you grow and be the best version of yourself.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 11-50 employees