Manager, Clinical Trials (Medtech)

TL;DR

Manager, Clinical Trials (Medtech): Managing all aspects of clinical trials from start-up through close-out with an accent on vendor/CRO management and regulatory compliance. Focus on ensuring study timelines, costs, and quality metrics are met within FDA and ICH-GCP frameworks.

Location: Remote (USA)

Salary: $115,800 - $144,700 USD

Company

Global leader in cell-free DNA (cfDNA) testing dedicated to oncology, women’s health, and organ health.

What you will do

• Manage complex clinical studies from start-up through close-out to ensure timelines, cost, and quality metrics are met.
• Select and oversee vendors and CROs to ensure project deliverables are executed within budget and protocol.
• Handle study contracting, budgeting, forecasting, and the payment process for all clinical trial vendors.
• Lead protocol and informed consent preparation, investigator selection, and TMF maintenance.
• Collaborate with Clinical Data Management to design CRFs, completion guidelines, and study reports.
• Hire, train, and oversee clinical trial staff while serving as a subject matter expert.

Requirements

• Bachelor’s degree in life sciences or a relevant discipline.
• 8 years of clinical research experience, with at least 4 years in a leading role managing 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.
• Ability to pass a post-offer criminal background check.

Nice to have

• Advanced degree in life sciences.
• Experience in managing CROs.

Culture & Benefits

• Comprehensive medical, dental, vision, life, and disability plans for employees and dependents.
• 401k and commuter benefits.
• Free genetic testing for employees and immediate families, including fertility care benefits.
• Pregnancy and baby bonding leave.
• Generous employee referral program.