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 te
a
• m Collaborates with Senior Leadership on study budgets and financial oversight for assigned projects. Owns the budget management process for assigned projec
t
• s Determines study project plan and objectives with appropriate stakeholders on an ongoing bas
i
• s 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 need
e
• d Delivers communication regarding key protocol questions to the study team and research sit
e
• s Develops, maintains and adapts study reports that assess key clinical study progre
s
• s Develops training materials and trains CVRx clinical staff and research sit
e
• s Assesses initial and ongoing qualifications and compliance of research sites, and applies resolutio
n
• s Interfaces with regulatory agencies (in conjunction with Regulatory personnel) regarding requirements and results of the stu
d
• y Oversees contract research organizations and other outside vendors (budgets, timelines, and complianc
e
• ) Evaluates clinical data/information, providing interim and final repor
t
• s Ensures compliance with study budget, SOPs and regulatio
n
• s Provides management, leadership and mentoring to clinical department sta
f
• f Completes special projects and performs other job-related duties as assign
e

tsWhat we Expect From You{​{:

}
• } Bachelor's degree in engineering, biological sciences or related medical/scientific fi
e
• ld 5-10 years experience directly supporting clinical research as part of a project team environment or similar experience in medical/scientific a
r
• ea Cardiovascular disease state experienc
e
• . Minimum of 5 years of clinical trial management experie
n
• ce Significant technical expertise (e.g., site management and monitoring, regulatory obligations
)
• . Project management tool experience (i.e. Microsoft Project, Smartsheet, Exc
e
• l) Knowledge of medical terminol
o
• gy Experience with GCPs/ISO 14155 and regulatory and compliance guidelines for clinical trial
s
• . IDE and post market trial experience for both US and
O
• US Significant knowledge of clinical research study des
i
• gn High attention to detail and accurac
y
• . Advanced problem-solving, oral and written communication skill
s
• . Able to manage multiple ta
s
• ks Comfortable in a fast-paced, high-growth company that is in the commercialization st
a
• ge Adaptable and embraces chang
e
• . Experience working on cross-functional te
a

ms What We'd Like To See{​{

:
• }} Normal office condit
i
• ons Must be able to sit/stand/walk 8 hours per
• day Position may require up to 30% travel, including internati
o
• nal May be required to be fully vaccinated against the COVID-19 virus and other dise
a

fitsWhat 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 contribu
t
• ions Company contributions to an HSA with a high deductible insuranc
e
• plan 401(k) with company
• match Employee stock purchase plan & stock option
g
• rants 12 company-paid holidays per year
• PTO Paid time off for new p
a
• rents Company-paid life insurance & disa
b
• ility Unlimited growth opportu
n
• ities Training & learning opportu
n
• ities Flexible Sch
e

dules EEO sta

tementCVRx, 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 train

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

ou!   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 fi