Study Manager (Biotech)

TL;DR

Study Manager (Biotech): Managing unblinded clinical trial operations for genetic medicine programs with an accent on maintaining strict firewalls and ensuring operational excellence. Focus on coordinating CROs, drug supply workflows, and data review processes to support clinical development milestones.

Location: Remote (US-based), with a preference for candidates based in the New England region.

Company

hirify.global is a clinical-stage biopharmaceutical company developing a new class of medicines to engage intracellular targets for the treatment of neuromuscular and inherited retinal diseases.

What you will do

• Serve as the unblinded operational lead for assigned clinical studies in compliance with ICH/GCP.
• Manage study activities including CRO oversight, site selection, and protocol implementation.
• Maintain firewalls between blinded and unblinded personnel to ensure study integrity.
• Support data review, reconciliation, and issue resolution with cross-functional teams.
• Contribute to inspection readiness and regulatory documentation.
• Provide flexible support during key milestones like dose escalations and database locks.

Requirements

• BA/BS degree with 7+ years of clinical operations experience.
• Direct experience in unblinded or partially blinded study management.
• Strong knowledge of ICH/GCP and global clinical trial regulatory expectations.
• Proven experience in trial design, planning, and vendor oversight.
• Must be based in the United States.
• Ability to travel occasionally for key meetings or site visits.

Nice to have

• Experience with EU-CTR.

Culture & Benefits

• Opportunity to work on cutting-edge genetic medicines for rare diseases.
• Collaborative, high-energy team environment.
• Focus on scientific innovation and patient impact.
• Flexible contract-based engagement.