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The BSM Specialist II/III is responsible for ensuring that incoming clinical trial and research projects are appropriately entered into laboratory information systems (LIMS) in order to ensure data integrity and conformance to project requirements prior to release of samples to the production laboratory operation.
Duties and Responsibilities
- Work cross functionally with computational biology and business development teams to generate data definitions and maps for incoming samples, as defined in data transfer agreements
- Ensure data definitions can be mapped to corresponding laboratory information management system (LIMS) fields, and hence ensure that data can be entered in a systematic manner
- Prepare manifests that ensure consistency of data entry, and hence data integrity
- Create projects in LIMS according to analytical plans or work orders
- Monitor progression of projects in order to anticipate sample arrival, and subsequently ensure appropriate release to the production facility for testing
- Ensure accuracy of project-related sample information at data entry and release to the production laboratory in order to ensure sample chain of custody
- Identify process interruptions, stalls and special handling needs - communicate to manager and other personnel, as needed. Assist in resolution of such events.
- Edit and author SOPs and documents specific to BSM data management functions: this may include sample/project tracking, sample distribution, and sample disposition
- Complete functions conforming to applicable regulations (CLIA, GCLP) as dictated by analytical plans, work orders or other project requirements.
- Work closely with customer care to manage sample discard or return, as needed.
- Compile status summaries and data reports, as needed
- Perform other duties as assigned by the BSM Project Manager.