Clinical Trial Manager/ Senior Clinical Trial Manager (Medtech)

TL;DR

Senior Clinical Trial Manager (Medtech): Leading the planning, conduct, and operational oversight of clinical studies with an accent on regulatory compliance, site feasibility, and vendor management. Focus on developing study-specific clinical documentation, managing eTMF implementation, and ensuring adherence to ICH-GCP standards.

Location: Remote, United States

Salary: $110,700 - $200,900 USD

Company

hirify.global is a clinical research organization specializing in the planning and execution of medical studies.

What you will do

• Lead the planning and operational conduct of clinical studies in accordance with protocols, SOPs, and ICH-GCP requirements.
• Act as the primary clinical point of contact for clients and collaborate with Project Managers on budget and invoicing.
• Develop essential study documentation, including clinical plans, Informed Consent Form templates, and training materials.
• Drive the site feasibility process, identify enrollment risks, and develop country-specific recruitment strategies.
• Oversee eTMF implementation and manage submissions to Competent Authorities and IRB/Ethics Committees.
• Collaborate with QA to develop and implement Corrective and Preventative Action Plans (CAPA).

Requirements

• Must be based in the United States.
• Bachelor's degree in a science or health-related field (advanced degree preferred).
• Minimum of 7 years of clinical research experience with significant clinical monitoring expertise.
• Mastery knowledge of ICH-GCP and regulatory guidance.
• Proven experience in functional management, risk management, and change management.
• Ability to travel domestically and internationally.

Culture & Benefits

• Comprehensive health insurance and disability benefits.
• Retirement savings benefits and life insurance.
• Paid time off for vacation and sick leave.
• Parental leave.
• Eligible for a discretionary annual bonus.