Senior Clinical Trial Associate (Medical)

TL;DR

Senior Clinical Trial Associate (Clinical Operations): Supporting the execution, start-up, and closeout of clinical trials for genetic medicines with an accent on ICH/GCP compliance and TMF maintenance. Focus on managing vendor payments, tracking trial progression, and ensuring regulatory documentation accuracy.

Location: Remote working model, requiring monthly or quarterly travel to the hirify.global Headquarters in Boston, MA

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases.

What you will do

• Support day-to-day operations of assigned trials from start-up to close-out in compliance with ICH/GCP guidelines.
• Maintain clinical trial tracking tools and provide regular updates on protocol deviations, adverse events, and site personnel trainings.
• Ensure timely maintenance, filing, and reconciliation of the Trial Master File (TMF) per regulatory standards.
• Manage vendor purchase orders, invoice reviews, and budget reconciliation.
• Coordinate clinical trial supplies and biosample management.
• Assist in external training for suppliers and clinical sites.

Requirements

• BA/BS degree.
• At least 2+ years of relevant experience in clinical operations within a biotech or pharmaceutical company.
• Strong understanding of all clinical trial phases from start-up to close-out.
• General working knowledge of drug development and ICH/GCP guidelines.
• Excellent interpersonal, written, administrative, and computer skills.

Nice to have

• Previous CRO or vendor management experience.

Culture & Benefits

• Remote working model with periodic travel to Boston HQ.
• Driven by values of humanity, tenacity, creativity, collaboration, and curiosity.
• Opportunity to work in a high-energy, dedicated team of experts in rare diseases.