Lead, Early-Phase Clinical Trials – Gene Editing

Arbor; Cambridge (MA); On-site; USD 145,000 - 170,000; Full time

Job summary

Arbor Biotechnologies seeks a Senior Clinical Trial Manager in Cambridge, MA to lead early-phase studies and report to the Senior Director of Clinical Operations. The role will manage trials from startup to close-out, overseeing study sites, master files, CROs, and study documentation.

The candidate will have 6+ years of progressive clinical operations experience in pharma/biotech, with strong GCP/ICH knowledge, and track record of delivering US/global trials on time and within budget.

Qualifications

• Bachelor’s degree required in life sciences or related field.
• 6+ years of progressive clinical operations experience in pharma/biotech.
• Experience managing early-phase clinical studies in rare diseases or novel platforms.

Responsibilities

• Oversee management of clinical study sites and CROs within budget, scope and schedule.
• Develop budgets and timelines for assigned trials.
• Support study protocols, ICFs, CRFs, SAPs, CSRs and related documents.
• Maintain trial master file and data validation.
• Coordinate cross-functional teams and stakeholder relationships.
• Travel domestically and internationally as needed.

Skills

GCP/ICH knowledge

Project management

Scientific communication

Team collaboration

Travel willingness

Education

Bachelor’s degree in life sciences

Tools

Smartsheet

Microsoft Office

Job description

Arbor Biotechnologies seeks a Senior Clinical Trial Manager in Cambridge, MA to lead early-phase studies and report to the Senior Director of Clinical Operations. The role will manage trials from startup to close-out, overseeing study sites, master files, CROs, and study documentation.

The candidate will have 6+ years of progressive clinical operations experience in pharma/biotech, with strong GCP/ICH knowledge, and track record of delivering US/global trials on time and within budget.