Senior Clinical Project Manager

Why work for CVRx?

CVRx pioneers' unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.

A day in the life:

The Senior Clinical Project Manager at CVRx is responsible for managing the development, implementation, and execution of clinical research studies consistent with clinical strategy, and applicable regulations and policies. The Senior Clinical Project Manager may also have management responsibilities of clinical department staff as position and team matures.

Key Duties and Responsibilities:

• Leads the development of the Investigational Plan and all associated documents in consultation with the cross-functional project team, investigators and the clinical team.
• Collaborates with Senior Leadership on study budgets and financial oversight for assigned projects. Owns the budget management process for assigned projects.
• Determines study project plan and objectives with appropriate stakeholders on an ongoing basis
• Oversees committee activities for assigned projects (i.e., Safety, DMC) and runs committee meeting. Works with the study team to prepare needed materials.
• Oversees monitoring requirements and activities for assigned projects and works with key stakeholders or the Safety and Monitoring Manager (if applicable) to develop the clinical safety and monitoring plans for assigned projects. . . .
• Manages site assigned Clinical Research CRA activities and participate in monitoring or site management activities as needed.
• Delivers communication regarding key protocol questions to the study team and research sites.
• Develops, maintains and adapts study reports that assess key clinical study progress.
• Develops training materials and trains CVRx clinical staff and research sites.
• Assesses initial and ongoing qualifications and compliance of research sites, and applies resolutions.
• Interfaces with regulatory agencies (in conjunction with Regulatory personnel) regarding requirements and results of the study.
• Oversees contract research organizations and other outside vendors (budgets, timelines, and compliance).
• Evaluates clinical data/information, providing interim and final reports.
• Ensures compliance with study budget, SOPs and regulations.
• Provides management, leadership and mentoring to clinical department staff.
• Completes special projects and performs other job-related duties as assigned.

Requirements

What we Expect From You:

• Bachelor's degree in engineering, biological sciences or related medical/scientific field.
• 5-10 years experience directly supporting clinical research as part of a project team environment or similar experience in medical/scientific area.
• Cardiovascular disease state experience.
• Minimum of 5 years of clinical trial management experience.
• Significant technical expertise (e.g., site management and monitoring, regulatory obligations).
• Project management tool experience (i.e. Microsoft Project, Smartsheet, Excel).
• Knowledge of medical terminology.
• Experience with GCPs/ISO 14155 and regulatory and compliance guidelines for clinical trials.
• IDE and post market trial experience for both US and OUS.
• Significant knowledge of clinical research study design.
• High attention to detail and accuracy.
• Advanced problem-solving, oral and written communication skills.
• Able to manage multiple tasks.
• Comfortable in a fast-paced, high-growth company that is in the commercialization stage.
• Adaptable and embraces change.
• Experience working on cross-functional teams.

What We'd Like To See:

• Normal office conditions.
• Must be able to sit/stand/walk 8 hours per day.
• Position may require up to 30% travel, including international.
• May be required to be fully vaccinated against the COVID-19 virus and other diseases.

Benefits

What we offer:

We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun. We also offer a competitive benefits package, details listed below:

• Health & Dental Insurance options with generous Company contributions
• Company contributions to an HSA with a high deductible insurance plan.
• 401(k) with company match.
• Employee stock purchase plan & stock option grants.
• 12 company-paid holidays per year + PTO.
• Paid time off for new parents.
• Company-paid life insurance & disability.
• Unlimited growth opportunities.
• Training & learning opportunities.
• Flexible Schedules.

EEO statement

CVRx, Inc.provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great thingsand a have a background in medical devices, healthcare or a related field, we want to hear from you!

If you need assistance or an accommodation due to a disability, you may contact us at hiring@cvrx.com

This requisition will be open until filled.

Qualification

Bachelor's Degree