Beschreibung
Job Focus:- Supports the Safety and Biomarker Lab staff and general study support
- Responds to requests and queries around lab data in support of study activities.
- Acts as data manager and is responsible for overall quality of lab data.
- Executes periodic database maintenance to include SQL scripts daily, weekly and at the end of a study
- Responds to software and hardware failures as needed.
- Works with partners to resolve issue
- Manages and groups data files by instrument in LIMS. Installs and updates instruments in LIMS and troubleshoots any issues that trace back to folder management.
- Works with the Lab Director to set up reference ranges and reflex tests using simple to complex Scripting
- Creates and maintains custom reports in LIMS using Business Objects Crystal Reports Develop barcode labels using a proprietary markup language
- Supports and performs standard LabWare LIMS training for the end user.
- Produce task-specific training material
- Sets up biomarker assays from scratch in LIMS which may include mapping of assay plates to transfer and retain sample location data.
- Scripts LabWare to locate, parse and load the data from reformatted spreadsheet.
- Rigorously tests in the Validation environment.
- Sets up and maintains the active instrument folders, LIMS scheduled tasks and the instrument interfaces
- Troubleshoots issues with the data in and between LIMS and PIMS Works closely with the PIMS administrator
- Executes periodic scripts or SQL extracts Scripts and provides extraction of data to Oracle Clinical (OC) Assists Lab personnel to champion business information solutions for the efficient delivery of quality data
- Develops and aligns processes within Labs and business partners.
- Provide strategic information technology input to the planning of solution delivery life cycle projects.
Qualifications:
- CPR Certified
- Bachelor's Degree in Information Technology discipline, or equivalent experience
- Fluency in Oracle SQL (PL/SQL to a lesser degree), Quest TOAD, Business Objects Crystal Reports, LabWare LIMS, Visual Basic-style script development
- Understanding of: N-tier system architecture, Programming concepts, Clinical testing concepts
- BLS certification
- Understanding of local regulatory requirements (eg ICH, GCP)
- Understanding of the drug development process Laboratory instrumentation and middle ware (Data Innovations, Dawning Technologies) used to connect instrumentation to a Lab Information System.
- General Lab Experience
- Prior Experience Preferred
- Proven ability to function as an effective and professional team member in diverse work groups to accomplish business objectives Excellent communication skills required (written, verbal, including telephone)
- Understanding of company data management standards and processes including GCDS, CAG, Oracle Clinical.
- Ability to align business processes with data requirements.
- Prior experience with electronic lab notebook software a plus
- Prior experience implementing or upgrading a Laboratory Information System a plus