Senior Clinical Trial Manager (Biotechnology)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Location: Hybrid in Cambridge, Massachusetts; onsite in the Cambridge office 2 days per week. Travel up to 10% of the time.
Base pay range: $142,800β$176,400 per year.
Company
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
- Bachelorβs 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.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β