Associate Clinical Project Manager

Introduction

We are a global medtech company dedicated to changing the trajectory of lives for a new day. Our mission is to create ingenious solutions that ignite patient turnarounds. Join our worldwide team to pioneer tomorrow.

we don't just treat conditions - we aspire to alter the course of lives.

Base salary: $95,000 - $105,000 + discretionary annual bonus. Pay ranges may vary by location.

• Coordinate project deliverables such as team meetings, budgets and timelines, and systems to track study metrics.
• Assist with the development and planning of clinical study strategies, design, protocols and other study‑related documents and tools.
• Provide clinical input for the design of case report forms and electronic databases.
• Prepare, coordinate and present regulatory applications, amendments, questions from authorities, supplements, reports and advisory panel presentations needed to conduct studies and approve products.
• Support clinical site selection, activation, management and close‑out activities throughout study conduct including all necessary documentation.
• Deliver clinical presentations to physicians, study staff, agents and distributors as required.
• Monitor or co‑monitor clinical study sites to ensure compliance with the approved protocol, plans and objectives, including reviewing clinical monitoring reports.
• Ensure clinical studies are adequately managed to meet protocol objectives and schedules.
• Support Data Monitoring Committees (aka Data Safety Monitoring Boards) and other committees/consultants established to support the studies.
• Assist data management staff with clinical data review and collection from sites, maintaining integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers and other issues identified.
• Develop and execute risk‑based study management process and plan according to study‑specific risk indicators and thresholds.
• Manage study vendors for compliance with study plans, objectives and vendor contracts, including tasks for labs and/or CROs as applicable.
• Ensure sponsor and site compliance with domestic and international regulations and guidelines.
• Communicate effectively with study management, participating sites and vendors on issues, questions and 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 (enrollment, regulatory approvals and renewals, payments) and systems (CTMS, EDC).
• For pre‑market studies, instruct warehouse and field staff in device distribution and recovery, maintaining device accountability plan and report.
• Coordinate and assist with data review, analysis and preparation of clinical study reports and delivery.
• Coordinate closeout of sites/studies and archive study documents.

• Minimum 4+ years as 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 terminology.
• Capability and willingness to learn device function.
• Ability to interface effectively with medical professionals.
• Strong analytical and organizational 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 organization, prioritizing assignments while handling multiple 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 studies.
• Experience as a Project Coordinator/Manager is a plus.

• Minimum Bachelor's Degree in Nursing (Master's Degree in Nursing accepted for candidates who did not complete an undergraduate nursing program).

• This position requires regular business travel of 25% or more of the time.

• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401(k))
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules