Senior Manager, Clinical Operations

Summary

Join Calyxo, a medical device company focused on improving kidney stone treatment, as a high-achieving Clinical Operations professional. You will lead and manage clinical trials, ensuring compliance with regulations and successful project execution. Responsibilities include developing study protocols, managing teams, overseeing monitoring, and preparing clinical reports. This role requires a BS in life sciences, 10+ years of relevant experience, and strong leadership skills. Calyxo offers a competitive salary ($166,000-$181,000), stock options, and a comprehensive benefits package including healthcare, 401(k), and paid time off. The company fosters a diverse and inclusive work environment.

Requirements

• BS degree in a life science
• 10+ years of relevant clinical experience in medical devices
• Extensive experience in full-cycle clinical project management
• Intimate working knowledge of US clinical research and medical device regulations
• Demonstrated leadership/management experience with the ability to work collaboratively and effectively with key opinion leaders and principal investigators
• 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 execute on multiple projects and/or studies to support the clinical operation goals that align with the company’s visions for evidence generation
• Provide cross-functional oversight of internal and contracted project team members and deliverables, while ensuring successful planning, implementation and conduct of ongoing clinical trials
• Develop study protocols and associated study documents as the project lead and clinical evidence generation subject matter expert
• Ensure clinical research is conducted in accordance with 21 CFR Part 812, 50 and 56 and applicable international standards
• Driving the Clinical team to deliver all clinical studies within the planned budget and timelines
• Responsible for timely study and program information within relevant tracking systems and provide management with regular updates regarding the status of all studies
• Drive study start up activities to identify, evaluate and qualify clinical sites to ensure compliance with applicable regulatory regulations
• Prepare, submit and negotiate effective and timely clinical site budgets and study contracts through to execution
• 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; overseeing monitoring and monitoring performance
• 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
• Identify, evaluate and manage CROs or vendors for study related services including but not limited to: data management, statistical analysis, monitoring
• Oversee the monitoring of clinical study data in eDC and other study databases
• Develop overall clinical study budgets and assist with development of clinical affairs budget
• Develop project management tools and study tracking tools and metrics and report to management
• Provide clinical input to new product development and business opportunities
• Conduct and summarize literature reviews in support of clinical activities
• Assist with coordination of data analysis and prepare clinical reports to support regulatory filings
• Assist with preparation and review of scientific publications
• 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 $166,000 - $181,000
• 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