Associate Clinical Project Manager

LivaNova•Chicago, IL

12d•$95,000 - $105,000

About The Position

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Additionally they will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts.

Requirements

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).

Nice To Haves

Experience as a Project Coordinator/Manager is a plus.

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.