Global Specimen Solutions (GSS) is wholly owned company of Covance Inc., providing specialty services in the holistic specimen tracking space. GSS improves translational science through industry best practices and a uniquely powerful pipeline data management analytics solution. GSS reduces the time, cost and risk of specimen based research, while building robust, healthy data pipelines that optimize research opportunities.
Performs monitoring of production data feeds including, but not limited to, examining the following.
Demonstrate the ability to multi-task and manage data monitor across multiple vendors and client instances
Plan and establish timelines to meet or exceed business expectations for data feed monitoring schedules.
Allocate time for investigation and resolution implementation.
Strong troubleshooting and analytical skills for identification of errors and resolution steps.
Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all staff.
There are no customer facing job functions in this position.
Support management of metrics.
Assist with investigating or resolving issues of quality as directed.
Staff and Financial Management
Understand implications of activities to project budgets.
Suggest process improvements where issues are seen.
Support Six Sigma process improvement teams.
Reviews training materials for staff.
Mentor and support other GSS employees in their understanding and adoption of data feed configuration and date point mapping development.
Active member of SOP review teams as assigned.
Lead or assist with special projects as designated.
Perform other duties as assigned by management.
Principal Contacts and Scope of Communications
Internal: GSS Client Project Managers, ClinRegOps (will need to get exact title of STPers from Doug), Data Architect, Data Monitor Specialist and Data Monitor Lead.
BS/BA degree preferably in the sciences or related field, or two (4) years in a data analysis and/or profiling.
Minimum 2 years to 4 year’s data informatics and analysis experience or equivalent work experience in a regulated (FDA, EPA, etc.) environment.
Strong attention to detail.
Strong analytical skills, preferably in a GCP environment.
Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
Problem Solving/Logic Skills.
Working knowledge of SQL preferred.
Experience with data profiling an advantage Strong communication and interpersonal skills.
Working knowledge of SQL and RDMS structures and relationships Strong MS/Office skills in particular with Excel and Word. Understanding of database query tools, such as DBForge or Navicat, preferred.