Pediatric Clinical Trials Lead - Stem Cell Transplant

Dana-Farber Cancer Institute; Brookline (MA); On-site; USD 95,000 - 114,000; Full time

Job summary

Dana-Farber Cancer Institute seeks a Clinical Pediatric Clinical Research Manager II to lead pediatric clinical research operations under GCP, reporting to the Clinical Trials Office and PI. You will manage day-to-day conduct of studies, ensuring quality, safety, regulatory compliance, and timely performance across the portfolio.

You will collaborate with physicians, nursing staff and program partners to plan, implement and evaluate activities, supervise staff, and drive budgetary and data

Qualifications

• Bachelor’s Degree required, with a minimum of 5+ years of related experience, or Master’s Degree with 5 years related experience.
• Experience in clinical research management and supervision.
• Strong regulatory, data management and analytical capabilities.

Responsibilities

• Oversee disease group’s clinical trial portfolio, including regulatory, compliance and performance metrics.
• Coordinate IRB submissions and collaborate with CTO, OHRS and ODQ to meet local and federal requirements.
• Develop protocol budgets with study administration and grants offices; manage financial reporting and staffing.
• Oversee procurement, inventory, and distribution of equipment used in trials; monitor study finances and expenditures.
• Assist PI in preparing manuscripts and develop study forms and data quality monitoring guidelines.
• Ensure subject enrollment, treatment and follow-up for protocol patients and oversee data entry and QA in the CTMS.

Education

Bachelor’s Degree

Master’s Degree

Tools

EPIC

OnCore

Livelink

Job description

Dana-Farber Cancer Institute seeks a Clinical Pediatric Clinical Research Manager II to lead pediatric clinical research operations under GCP, reporting to the Clinical Trials Office and PI. You will manage day-to-day conduct of studies, ensuring quality, safety, regulatory compliance, and timely performance across the portfolio.

You will collaborate with physicians, nursing staff and program partners to plan, implement and evaluate activities, supervise staff, and drive budgetary and data