Georgetown University Medical Center (GUMC) is seeking a Research Data Manager to manage data for a portfolio of clinical trials, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Requirements
- Competent in Microsoft Word, Excel, Access and PowerPoint
- Experience with web-based Electronic Data Capture (EDC) and clinical data management systems preferred
- Knowledge of data abstraction methods
- Detail oriented with excellent analytical skills
Responsibilities
- Responsible for overseeing the delivery of high-quality clinical research data for complex clinical trials across multiple studies and therapeutic areas, from study start-up and planning through execution and closeout
- Supports multiple clinical research studies
- Demonstrates a general understanding of each assigned clinical research protocol, critical tasks and milestones
- Ensures accurate, complete, and timely data entry and reporting in accordance with study protocols, institutional policies, and regulatory standards
- Coordinates and executes data management activities across a portfolio of investigator-initiated, federally funded, and industry-sponsored studies
- Works collaboratively with CRCs, PIs, Clinical staff, Biostatisticians, Regulatory staff, and study sponsors to meet project deliverables and timelines for data acquisition, quality checking, and reporting
- Maintains the integrity of clinical research data for non-oncology clinical trials
Other
- Bachelor’s Degree in science related field and at least 3 years of related experience
- Strong organizational skills
- Excellent interpersonal, written and organizational communication skills
- Ability to maintain confidentiality, prioritize, and meet deadlines
- Must be able to work on-campus; work mode designations are subject to change
