Associate, Clinical Trial Operations (Biotech)

TL;DR

Associate, Clinical Trial Operations (Biotech): Providing operational support to clinical study teams for multiple clinical trials with an accent on TMF management, regulatory compliance, and vendor coordination. Focus on ensuring adherence to SOPs, FDA regulations, and GCP/ICH guidelines across all phases of clinical research.

Location: Must be based in the U.S. (Fully remote with 25% travel requirement).

Salary: $87,000–$111,000 Annual

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage and maintain paper and electronic Trial Master Files (TMF) ensuring quality control and compliance.
• Partner with Quality Assurance to assist in audits and inspections for CROs and vendors.
• Review clinical trial agreements, work orders, and vendor invoices.
• Track and document site and sponsor training activities.
• Coordinate regulatory inspection activities including document retrieval and preparation.
• Participate in clinical study team meetings and manage action items.

Requirements

• Bachelor’s degree in life science, healthcare, or a related field.
• 1+ year of experience in the pharmaceutical or biotech industry.
• Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Strong verbal and written communication skills.
• Ability to work effectively in a global, multi-functional matrix environment.
• Must be authorized to work in the U.S.

Nice to have

• Experience with paper and electronic TMF (eTMF) systems.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and family-forming benefits.
• Access to the Company Learning Institute for professional development.
• Supportive culture focused on patient impact and employee well-being.