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Overview
We’re partnered with a rapidly growing biotechnology company focused on building, acquiring, and funding businesses that develop and commercialize innovative pharmaceutical products.
The
Site Director, Clinical Operations
will lead all aspects of clinical site management, including site selection, feasibility, study start‑up, initiation, patient recruitment, monitoring, close‑out, and inspection readiness. This role ensures compliance with study protocols, SOPs, ICH‑GCP, and all applicable regulatory requirements. Must be located within the Northeast territory to cover the respective region.
Responsibilities
Oversee the successful start‑up, monitoring, and execution of Phase I–IV clinical trials at assigned sites.
Manage all site activities in accordance with ICH‑GCP guidelines, SOPs, study protocols, and applicable local regulations.
Act as the primary liaison for clinical sites throughout all study phases, from initiation to close‑out.
Build and maintain strong relationships with investigators and site staff to ensure consistent engagement and performance.
Partner with sites to address protocol compliance, recruitment challenges, deviations, and inspection readiness.
Support continuous improvement by sharing best practices and contributing to clinical operations process enhancements.
Qualifications
Bachelor’s Degree in a Life Science discipline required.
Bachelor’s Degree in Nursing or RN a plus.
Minimum 3 years of direct site monitoring experience required.
Must be willing and able to travel up to 50‑65%.
Job Details
Travel: up to 50‑65%
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research and Science
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Benefits
Medical insurance
Vision insurance
401(k)
Location & Salary Waltham, MA $180,000.00‑$235,000.00 (3 days ago)
#J-18808-Ljbffr
The
Site Director, Clinical Operations
will lead all aspects of clinical site management, including site selection, feasibility, study start‑up, initiation, patient recruitment, monitoring, close‑out, and inspection readiness. This role ensures compliance with study protocols, SOPs, ICH‑GCP, and all applicable regulatory requirements. Must be located within the Northeast territory to cover the respective region.
Responsibilities
Oversee the successful start‑up, monitoring, and execution of Phase I–IV clinical trials at assigned sites.
Manage all site activities in accordance with ICH‑GCP guidelines, SOPs, study protocols, and applicable local regulations.
Act as the primary liaison for clinical sites throughout all study phases, from initiation to close‑out.
Build and maintain strong relationships with investigators and site staff to ensure consistent engagement and performance.
Partner with sites to address protocol compliance, recruitment challenges, deviations, and inspection readiness.
Support continuous improvement by sharing best practices and contributing to clinical operations process enhancements.
Qualifications
Bachelor’s Degree in a Life Science discipline required.
Bachelor’s Degree in Nursing or RN a plus.
Minimum 3 years of direct site monitoring experience required.
Must be willing and able to travel up to 50‑65%.
Job Details
Travel: up to 50‑65%
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research and Science
Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Benefits
Medical insurance
Vision insurance
401(k)
Location & Salary Waltham, MA $180,000.00‑$235,000.00 (3 days ago)
#J-18808-Ljbffr