Clinical Trial Manager (Biotech)

TL;DR

Clinical Trial Manager (Biotech): Managing the planning and execution of global Phase I–III clinical trials with an accent on CRO oversight, study start-up, and GCP compliance. Focus on coordinating cross-functional teams, ensuring inspection readiness of TMF documentation, and optimizing site activation for CNS disorder studies.

Location: Boston, Massachusetts (Hybrid: 3 days per week in office)

Company

hirify.global is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies.

What you will do

• Lead the planning, execution, and oversight of global Phase III clinical trials from start-up to close-out.
• Develop and track essential study documents, including protocols, ICFs, and investigative brochures.
• Manage CROs and vendors, monitoring performance metrics to ensure high-quality deliverables.
• Oversee TMF/eTMF documentation to maintain a continuous state of inspection readiness.
• Coordinate cross-functional study meetings and proactively communicate updates to internal and external stakeholders.
• Identify and resolve site risks and issues to foster positive site relationships and manage enrollment.

Requirements

• Bachelor’s degree in life sciences or healthcare related field.
• 5+ years of clinical operations experience within the biotech or pharma industry.
• Experience managing outsourced global clinical trials across Phase I–III.
• Solid understanding of GCP, ICH guidelines, and the clinical development process.
• Proficiency with clinical trial management systems (CTMS), eTMF, and other operational tools.
• Must be based in Boston, MA for a hybrid work arrangement (3 days/week in office).

Nice to have

• Prior involvement in study start-up activities.

Culture & Benefits

• Access to continuous training and professional development within a global CRO.
• Inclusive work environment celebrating diversity in gender, race, and beliefs.
• Company culture with below-industry average turnover rates.
• Direct-hire permanent position.

Hiring process

• CV submission and initial screening.
• Phone interview for candidates meeting the requirements.