Clinical Manager, Clinical Operations - Remote

Overview

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 Short

• 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.

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

Benefits

• 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