Clinical Operations Specialist, BIOSPECIMEN DATABASE MANAGEMENT
Celgene - San Francisco, CA
6 months with a possibility to extend
CORE JOB FUNCTIONS:
- The TD Operations group provides biospecimen management for Celgene-sponsored biomarker clinical trials in hematology/oncology and inflammation/immunology.
- Manage a centralized sample repository database called Labmatrix and assist with the migration of current studies which involves working clinical data listings and developing data transfer templates with vendors.
- Use the system to track biospecimens, identify and resolve discrepancies, verify and document consent, and ensure compliant utilization of biospecimens by following written procedures.
- Bachelor's Degree preferably in the life sciences with 2-4 years biorepository database experience in a clinical/diagnostic laboratory or pharmaceutical/biotechnology R&D environment.
- Demonstrated understanding of basic principles in clinical research and biospecimen processing procedures involving blood and tumor biopsies.
- Experience in working with clinical trial protocols and informed consents.
- Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation.
- Computer skills: detailed knowledge of at least one data management system experience with SAS data sets and conversion procedures required; knowledge of MS Office program suite required.
- Excellent skills in SAS and/or R programming preferred.
- Intermediate-level Excel is a plus.
- Experience with Labmatrix is a plus.
- A team-player who is detail-oriented
- Can successfully multi-task, supporting several projects simultaneously
- Knows how to identify/recognize issues and propose solutions with moderate guidance