Pediatric Cell Therapy Clinical Trials Lead

Dana-Farber Cancer Institute; Brookline (MA); Hybrid; USD 77,000 - 103,000; Full time

Job summary

Dana-Farber Cancer Institute in the Boston area is seeking a Clinical Research Manager to lead a disease group’s clinical trial portfolio, ensuring regulatory compliance and performance metrics. You will collaborate with physicians, nursing staff, and research administration to design, implement, and evaluate trial activities and budgets.

The role involves supervising research staff, coordinating regulatory filings, data quality control, and ensuring patient safety across therapeutic and

Responsibilities

• Oversight of disease group’s clinical trial portfolio and regulatory, compliance and performance metrics requirements
• Collaborate with IRBs, CTO, OHRS, and ODQ to fulfill local and federal requirements
• Identify and manage operational, logistical, and regulatory challenges
• Assist PI in protocol budgeting with Research Administration and Grants offices
• Oversee procurement, receipt, inventory and distribution of trial equipment
• Maintain study finances with grant managers and financial officers
• Assist in manuscript preparation
• Develop study forms and data quality guidelines with CTO/ODQ for PI Initiated studies / Multi-Center Trials
• Oversee subject enrollment, protocol treatment and follow-up for protocol patients
• Register protocol patients with ODQ or OnCore policies and pharmaceutical company guidelines

Job description

Dana-Farber Cancer Institute in the Boston area is seeking a Clinical Research Manager to lead a disease group’s clinical trial portfolio, ensuring regulatory compliance and performance metrics. You will collaborate with physicians, nursing staff, and research administration to design, implement, and evaluate trial activities and budgets.

The role involves supervising research staff, coordinating regulatory filings, data quality control, and ensuring patient safety across therapeutic and