Calico is seeking to manage the lifecycle of clinical samples efficiently and ensure compliance with clinical protocols, regulatory requirements, and ethical standards.
Requirements
- Strong proficiency with electronic data management systems (LIMS) and sample tracking software
- Proficiency with Microsoft Office, advanced Microsoft Excel skills preferred
- Demonstrated understanding of ICH, GCP, and GLP guidelines
- Prior experience building LIMS system (nice to have)
- Previous oncology drug development experience (nice to have)
Responsibilities
- Coordinate biosample logistics from clinical sites to central labs and analysis laboratories
- Manage query resolution and documentation
- Contribute to development of biosample management plans (BMPs), study protocols, ICFs, lab manuals and other relevant study documents
- Assist with process improvement activities for biosample operations including development of vLIMS and biomarker data management systems
- Participate in study team meetings and provide updates on sample operational status
- Ensure compliance with clinical trial protocols, regulatory guidelines, and Good Clinical Practice (GCP)
- Collaborate with Biomarker and Clinical teams to ensure sample and data delivery and support data analysis and interpretation
Other
- Bachelor’s degree in a life sciences discipline or related field
- Minimum of 5 years’ experience in laboratory setting or sample management within the biotechnology or pharmaceutical industry
- Excellent organizational, interpersonal, and communication skills
- Demonstrated ability to establish priorities, work independently and collaborate effectively with the cross-functional team and external partners/vendors
- Must be willing to work onsite at least four days a week
