Associate Clinical Project Manager

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, Liva Nova is where your talent can truly thrive.

Join our talented team members worldwide to become a pioneer of tomorrow—because at Liva Nova,
we don t just treat conditions — we aspire to alter the course of lives.

Role overview

The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. 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.

• 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 Liva Nova 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 (e.g., enrollment, regulatory approvals and renewals, payments) and systems (e.g., CTMS, EDC).
• For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report.
• Coordinate and assist with the data review, analysis and preparation of the clinical study reports and coordinate their deliveries.
• Coordinate closeout of sites/study, archive study documents.

• 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 (ISO
  14155/GCP) and clinical study design and implementation.
• Working knowledge of medical…