Clinical Trial Manager (Medtech)

TL;DR

Clinical Trial Manager (Medtech): Managing all aspects of clinical trials from start-up through close-out with an accent on vendor/CRO management, regulatory compliance, and study timelines. Focus on overseeing complex clinical studies, managing budgets and forecasting, and ensuring adherence to FDA and ICH-GCP guidelines.

Location: Remote (USA)

Salary: $138,600 - $173,300 USD

Company

hirify.global is a global leader in cell-free DNA (cfDNA) testing dedicated to oncology, women's health, and organ health.

What you will do

• Manage the execution of complex clinical studies to ensure timelines, costs, and quality metrics are met.
• Select and provide ongoing management to CROs and vendors to ensure compliance with budgets and study protocols.
• Oversee study contracting, budgeting, forecasting, and payment processes for all clinical trial vendors.
• Lead study activities including protocol preparation, investigator selection, training material development, and TMF maintenance.
• Collaborate with Clinical Data Management to design CRFs, completion guidelines, and study reports.
• Develop Clinical Department SOPs and participate in audits.

Requirements

• Bachelor’s degree in life sciences or other relevant discipline.
• 8 years of clinical research experience, including at least 4 years in a leading role managing clinical trials.
• 4-7 years of experience supporting clinical trials in a regulated environment.
• Deep knowledge of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs.
• Must be based in the USA.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• Free genetic testing and fertility care benefits for employees and immediate families.
• Pregnancy and baby bonding leave.
• 401k and commuter benefits.
• Collaborative environment working alongside industry elite to change genetic disease management.