Clinical Project Manager - Pleasanton, CA

About the 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.

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 CRA’S 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
• AID IN IDENTIFYING, EVALUATING AND MANAGING CRO’S 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
• AID IN COORDINATION OF DATA ANALYSIS AND PREPARE CLINICAL REPORTS TO SUPPORT REGULATORY FILINGS
• AID IN DEVELOPMENT OF CLINICAL STRATEGY, WHICH INCLUDES THE PREPARATION OF CLINICAL PROTOCOLS AND INVESTIGATIONAL PLANS

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. 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 Power Point, Excel and eDC platforms
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer

• 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

Legal Authorization

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.

Disclaimer

We prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.