Clinical Data Operations Specialist

Foundation Medicine, Inc.; Morrisville (NC); In loco; USD 53.000 - 67.000; Tempo pieno

Descrizione del lavoro

Foundation Medicine, Inc. is seeking an Associate in Clinical Data Operations to support data management for BioPharma, FMI and Academic collaborators. You will help ensure sample tracking, data entry, query resolution, and timely data reporting across complex studies.

The role emphasizes collaboration with internal teams, adherence to HIPAA and regulatory standards, and contributing to process improvements while supporting partner milestones.

Competenze

• Basic qualifications require a Bachelor's Degree in a health or science field.
• Preferred qualifications include 1+ year of professional work experience in science/health, familiarity with oncology, clinical research, molecular biology or bioinformatics.
• Strong attention to detail and ability to work cross-functionally under deadlines are desired.

Mansioni

• Provide ongoing study operational support and maintain study folder structures in TMF.
• Monitor archiving, track sample processing, and generate study-specific sample status reports.
• Manage query processes with partners and complete Study Intake in the CTMS/CRM.
• Ensure data quality and HIPAA, GDP, and GCP compliance across reporting activities.
• Collaborate with Bioinformatics, Data Management, Clinical Operations, Lab Operations and Tech teams on reporting workflows.

Conoscenze

Attention to detail

Cross-functional teamwork

Verbal and written communication

Organizational skills

Time management under deadlines

HIPAA compliance knowledge

Formazione

Bachelor's Degree in health or science

Strumenti

CRM

Data management systems

Descrizione del lavoro

Foundation Medicine, Inc. is seeking an Associate in Clinical Data Operations to support data management for BioPharma, FMI and Academic collaborators. You will help ensure sample tracking, data entry, query resolution, and timely data reporting across complex studies.

The role emphasizes collaboration with internal teams, adherence to HIPAA and regulatory standards, and contributing to process improvements while supporting partner milestones.