Clinical Manager, Clinical Operations - Remote

ZipRecruiter; Pleasanton (CA); Remote; USD 139,000 - 152,000; Full time

Job summary

An established industry player in the medical device sector is seeking high achievers to join their dynamic team in Pleasanton. This role focuses on managing clinical studies and ensuring compliance with regulatory standards, contributing to innovative kidney stone treatment solutions. With a commitment to growth and a diverse work environment, the company offers competitive salaries, stock options, and comprehensive benefits. If you have a strong background in clinical project management and a passion for improving patient outcomes, this opportunity could be your next career step.

Benefits

Stock options

401(k)

Healthcare

Paid time off

Qualifications

• 5-10 years of relevant clinical experience in medical devices.
• Strong knowledge of US clinical research and medical device regulations.
• Detail-oriented with excellent organizational and communication skills.

Responsibilities

• Manage clinical studies to meet operational and evidence goals.
• Oversee all phases of clinical studies, including document management.
• Negotiate budgets and contracts with clinical sites.

Skills

Clinical project management

Regulatory compliance

Communication skills

Organizational skills

Collaboration

Statistical knowledge

Education

BS in life science

Tools

PowerPoint

Excel

eDC platforms

Job description

Job Description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. Founded in 2016, our mission is to improve kidney stone treatment. We are led by experienced executives and investors with a proven track record in bringing innovative urology devices to market.

We are seeking high achievers to join our dynamic team in a diverse and engaging environment. If you're ready to contribute to the future of kidney stone treatment, consider this opportunity.

In This Role, You Will:

• Manage clinical studies to meet operational and evidence goals aligned with company vision.
• Ensure compliance with 21 CFR Part 812, 50, 56, and international standards.
• Oversee all phases of clinical studies, including document management, IRB support, recruitment, and site payments.
• Qualify and evaluate clinical sites for regulatory compliance.
• Negotiate budgets and contracts with clinical sites.
• Prepare monitoring guidelines and study materials.
• Manage and train CRAs, review site reports, and conduct initiation visits.
• Provide surgical and clinical trial training, and facilitate investigator meetings.
• Assist in selecting and managing CROs and vendors.
• Escalate issues to management and provide technical support during research.
• Monitor data, assist in cleaning databases, and develop project tracking tools.
• Support clinical strategy development, including protocol preparation.
• Perform other duties as assigned.

Reporting and Supervisory Structure

• Reports to: Director, Clinical Operations
• Supervises: CRAs (contract and internal)

Requirements

• BS in a life science field.
• 5-10 years of relevant clinical experience in medical devices.
• At least three years of full-cycle clinical project management experience.
• Strong knowledge of US clinical research and medical device regulations.
• Ability to collaborate across departments, prioritize, and manage multiple tasks.
• Detail-oriented with excellent organizational and communication skills.
• Medical background with understanding of clinical research and statistics; urology experience is a plus.
• Proficient in PC software, PowerPoint, Excel, and eDC platforms.
• Willingness to travel up to 50%.

What We Offer

Join a knowledgeable, high-achieving team committed to growth and innovation. Enjoy a diverse work environment, ongoing learning, and leadership opportunities.

• Competitive salary: $139,000 - $152,000
• Stock options and ownership stake
• Benefits: 401(k), healthcare, paid time off

We value diversity and are an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, genetics, veteran status, or other protected characteristics. Legal authorization to work in the U.S. is required, and verification will be conducted upon hire.