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Senior Clinical Trial Manager (Biotechnology)

142Β 800 - 176Β 400$
Π€ΠΎΡ€ΠΌΠ°Ρ‚ Ρ€Π°Π±ΠΎΡ‚Ρ‹
hybrid
Π’ΠΈΠΏ Ρ€Π°Π±ΠΎΡ‚Ρ‹
fulltime
Π“Ρ€Π΅ΠΉΠ΄
senior
Английский
b2
Π‘Ρ‚Ρ€Π°Π½Π°
US
Вакансия ΠΈΠ· списка Hirify.GlobalВакансия ΠΈΠ· Hirify Global, списка ΠΌΠ΅ΠΆΠ΄ΡƒΠ½Π°Ρ€ΠΎΠ΄Π½Ρ‹Ρ… tech-ΠΊΠΎΠΌΠΏΠ°Π½ΠΈΠΉ
Для мэтча ΠΈ ΠΎΡ‚ΠΊΠ»ΠΈΠΊΠ° Π½ΡƒΠΆΠ΅Π½ Plus

ΠœΡΡ‚Ρ‡ & Π‘ΠΎΠΏΡ€ΠΎΠ²ΠΎΠ΄

Для мэтча с этой вакансиСй Π½ΡƒΠΆΠ΅Π½ Plus

ОписаниС вакансии

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TL;DR
Senior Clinical Trial Manager (Biotechnology): Managing clinical studies, CROs, vendors, timelines, budgets, and trial documentation for engineered-organ development programs with an accent on cross-functional coordination, GCP compliance, and audit readiness. Focus on overseeing clinical sites and external partners, maintaining the Trial Master File, identifying timeline risks, and resolving audit findings.

Location: Hybrid in Cambridge, Massachusetts; onsite in the Cambridge office 2 days per week. Travel up to 10% of the time.

Base pay range: $142,800–$176,400 per year.

Company

hirify.global is a clinical-stage biotechnology company developing human-compatible engineered organs to address the global organ shortage.

What you will do

  • Manage day-to-day clinical trial activities, study timelines, budgets, CROs, and external vendors.
  • Prepare and review protocols, informed consents, study plans, lab manuals, case report forms, clinical study reports, and related documentation.
  • Coordinate communication across Regulatory, Quality, GMP Production, Development, clinical sites, and CROs.
  • Ensure studies follow SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
  • Set up and maintain the Trial Master File and keep clinical trial documentation audit-ready.
  • Lead internal study team calls, track milestones, identify timeline risks, and coordinate mitigation and audit-finding resolution.

Requirements

  • Bachelor’s degree; a life science or medical background is preferred.
  • 7+ years of experience in life sciences or a medically related field, including 4+ years of biopharmaceutical clinical research experience.
  • Experience working on clinical trials at a biotechnology, pharmaceutical, or CRO company.
  • Experience overseeing external vendors such as CROs and central laboratories.
  • Working knowledge of Good Clinical Practices and relevant regulatory requirements.
  • Ability to work onsite in the Cambridge office 2 days per week and travel up to 10% of the time.

Culture & Benefits

  • Collaborative work across Clinical Development, Regulatory, Quality, GMP Production, and Development.
  • Work on clinical programs involving genetically engineered porcine organs and genome engineering.
  • Resourceful, detail-oriented environment focused on clear communication and cross-functional execution.
  • Full-time hybrid work arrangement.

Π‘ΡƒΠ΄ΡŒΡ‚Π΅ остороТны: Ссли Ρ€Π°Π±ΠΎΡ‚ΠΎΠ΄Π°Ρ‚Π΅Π»ΡŒ просит Π²ΠΎΠΉΡ‚ΠΈ Π² ΠΈΡ… систСму, ΠΈΡΠΏΠΎΠ»ΡŒΠ·ΡƒΡ iCloud/Google, ΠΏΡ€ΠΈΡΠ»Π°Ρ‚ΡŒ ΠΊΠΎΠ΄/ΠΏΠ°Ρ€ΠΎΠ»ΡŒ, Π·Π°ΠΏΡƒΡΡ‚ΠΈΡ‚ΡŒ ΠΊΠΎΠ΄/ПО, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡ‚Π΅ этого - это мошСнники. ΠžΠ±ΡΠ·Π°Ρ‚Π΅Π»ΡŒΠ½ΠΎ ΠΆΠΌΠΈΡ‚Π΅ "ΠŸΠΎΠΆΠ°Π»ΠΎΠ²Π°Ρ‚ΡŒΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡˆΠΈΡ‚Π΅ Π² ΠΏΠΎΠ΄Π΄Π΅Ρ€ΠΆΠΊΡƒ. ΠŸΠΎΠ΄Ρ€ΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β†’