Description
Job Responsibilities:-
Follow GCP and GLP compliant processes -
Responsible for study database design in Laboratory Information Management System (LIMS) used for tracking study samples and analytical results -
Responsible for creation of Java mapping programs which combine study database design with electronic manifests from external vendors -
Responsible for sample data QC, discrepancy identification, and sample information import into LIMS -
Consulted by Project Managers in the development of procedures and protocols that ensure sample handling and sample information tracking follow all required GLP and GCP regulations -
Consulted on third party vendor Scope of Work documents to provide input on electronic manifest information and sample identification requirements -
Responsible for creating database keys that relate information within LIMS with sample label identifiers and Clinical database fields -
Responsible for providing laboratory personnel with sample handling requirements to ensure that received samples are properly handled and cataloged in preparation for assays based on study needs -
Responsible for updates to study database design and sample information in accordance to study timelines -
Responsible for creating study specific documentation related to deviations from standard procedures related to LIMS activities which are not subject to additional approval -
Consulted by project and data managers on cross-functional data workflows for scenarios involving both internal and external sample and results management
Skills / Education:
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BA/BS is required and a life sciences degree is preferred -
2-4 years pharmaceutical/biotech industry experience
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Previous experience working with biologic samples and associated LIMS -
Proficiency with PC systems, including email, calendar, and Microsoft Office applications -
Proficiency with Java programming -
Proficiency with data manipulation in Microsoft Excel -
Proficiency with Electronic Sample Tracking Systems -
Proficiency with GLP and GCP Regulations -
Proficiency in managing simultaneous responsibilities while adhering to project deadlines -
Ability to work independently and to solve common problems without management input
To find out more about Real please visit www.realstaffing.com