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.
-File delivery schedule met. Data feed executed to completion correctly.
-Number of record errors, by category, is within acceptable tolerance by error type.
-Number of record errors not categorized.If error matches known error type, with known standard resolution, implement known resolution.For unknown errors, investigate to point of understanding resolution, or as far as possible. Escalate findings to Data Monitor Lead.Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
-Develop new standard monitoring scripts for unknown errors and develop standard resolutions instructions.
-Manually re-execute data load for data feeds that have had standard resolutions applied.
-Triages unacceptable errors for resolution.
Function Specific
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.
Customer Facing
There are no customer facing job functions in this position.
Metrics
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.
Process Improvement
Suggest process improvements where issues are seen.
Support Six Sigma process improvement teams.
Training / SOPs
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.
Other
-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.
Education/Qualifications
Minimum Required:
-BS/BA degree preferably in the sciences or related field, or two (4) years in a data analysis and/or profiling.
Experience
Experience
-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.
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