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 ClinicalProjectManagerplays 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. This positioncollaborates closely with internal stakeholders and external partnersincluding CRAs CROs and clinical sitesto 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 effectivelymanage clinicalstudies to support the clinical operation goals that align with the companys visions for evidence generation
• Ensure clinical research is conductedin accordance with21 CFR Part 812 50 and 56 and applicable international standards(ISO 14155:2026)
• Identifyevaluateand qualify clinical sites to ensure compliance with applicable regulatory regulations
• Assistin negotiating clinical site budgets and study contracts
• Prepare clinical monitoring guidelines
• Generate various study and training materials to support clinical trials
• Source manage and traincontractCRAs assigned to study sites
• Review and approve CRAmonitoringtrip reports
• Conduct site initiation visitsand monitoring visitsand 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
• Assistinidentifyingevaluatingand managingCROs or vendors for study related services including but limitedto:data management statistical analysis monitoring
• Provide technicaleDCand clinical support during clinical research
• Monitor clinical study data andassistin cleaning ofeDCand 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
• Assistwith coordination of data analysis and prepare clinical reports to support regulatory filings
• Assistwith 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:

• Degree in a life science(BS or MS)
• 7years of relevant clinical experience in medical devices(or a combination of pharma and med devices)
• At leastfouryears 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 displayinitiativeand 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 researchpreferable.
• Proficient with PC and associated software. Strong technicalwrittenand communication skills.
• Ability to travel up to50% of the time
• Proficiencyin Power Point Excel andeDCplatforms
• Compliance with relevant county state and Federal rulesregardingvaccinations.

WhatWeOffer:

AtCalyxo you will be part of a knowledgeable high-achievingexperiencedand 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 offeran attractivecompensation package which includes:

• A competitivebasesalary range of $140000 - $150000and variable incentive plan
• Stock options ownership and a stake in growing amission-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 onlyvalued but alsoprioritized. 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 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:

At Calyxo 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. If you receive a request for information from any other domain please contact us directly at to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.