Job description
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.
In This Role, You Will:
- 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
- Independently manage all phases of a clinical study including essential document management, contract review, IRB/EC support, recruitment, site payment reconciliation, and development of site tools
- 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 CRAs assigned to study sites
- Review and approve CRA site monitoring trip reports
- Conduct site initiation 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
- Ability to escalate significant issues to senior management in a timely manner, while working to resolve site-specific challenges
- 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 and study tracking tools to report on metrics
- Assist with data analysis and summarizing to report to management
- 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:
- Director, Clinical Operations
Supervisory Responsibilities:
- CRAs (contract and internal)
Requirements:
- BS degree in a life science.
- 5 to 10 years of relevant clinical experience in medical devices.
- At least three 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
What We Offer:
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 a compensation plan as follows:
- Competitive base salary of $139,000 - $152,000
- Stock options – ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid time off
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 and to complete the required employment eligibility verification form upon hire.
