LivaNova · 6 hours ago
Associate Clinical Project Manager
Minneapolis, MN
Full-time
Onsite
Mid Level
$95K/yr - $105K/yr
4+ years expLivaNova is a global medtech company committed to changing lives through innovative healthcare solutions. The Associate Clinical Project Manager will assist in managing and executing clinical studies, develop clinical trial strategies, and ensure compliance with regulations to support successful product development.
Health CareMedical DeviceNeuroscience
Responsibilities
Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics
Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools
Oversee and provide clinical input for the design of the Case Report Forms and electronic databases
Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products
Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation
Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required
Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports
Assure clinical studies are adequately managed to meet the protocol objectives and schedules
If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies
Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified
Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds
Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable
Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines
Effectively communicate with LivaNova study management, participating sites, and any vendors on issues, questions and/or study updates
Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times
Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC)
For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report
Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries
Coordinates closeout of sites/study, archive study documents
Qualification
Required
Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO
Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation
Working knowledge of medical terminology
Capability and willingness to learn device function
Ability to interface effectively with medical professionals
Strong analytical and organization skills, with excellent attention to detail and accuracy
Project oversight and tracking capability
Good oral and written communication skills
Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously
Experience with electronic data capture (EDC) and clinical trial management systems (CTMS)
Demonstrated ability to perform in a team environment
Ability to travel as necessary to clinical centers to establish and manage clinical studies
Minimum Bachelor's Degree in Nursing (a Master's Degree in Nursing is also accepted for candidates who did not complete an undergraduate nursing program)
This position requires regular business travel of 25% or more of the time
Preferred
Experience as a Project Coordinator/Manager is a plus
Benefits
Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules
Company
LivaNova
LivaNova is a medical technology company that specializes in advanced cardiac surgery, neuromodulation, and circulatory support solutions.
1001-5000 employees
H1B Sponsorship
LivaNova has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (7)
2023 (6)
2022 (7)
2021 (9)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$300M2024-03-05Post Ipo Debt· $300M
2015-10-19IPO
Leadership Team
Vladimir Makatsaria
Chief Executive Officer
Alex Shvartsburg
Chief Financial Officer
Recent News
News-Medical.Net
2026-01-16
2025-12-24
Company data provided by crunchbase