Clinical Manager, Clinical Operations

Summary

Join Calyxo, a medical device company focused on improving kidney stone treatment, as a Clinical Project Manager. You will manage all phases of clinical studies, ensuring compliance with regulations. Responsibilities include managing clinical sites, preparing study materials, training CRAs, conducting site visits, and assisting with data analysis. The ideal candidate possesses a BS in life sciences, 5-10 years of relevant clinical experience, and at least three years of full-cycle clinical project management experience. Calyxo offers a competitive salary, stock options, and an employee benefits package including 401(k), healthcare insurance, and paid time off. The company fosters a diverse and inclusive work environment.

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
• 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

Responsibilities

• 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

Preferred Qualifications

Background in urology research preferable

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