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.
- Reviews vendor data feed for completeness and accuracy against client instance definition.
- Evaluates appropriateness of vendor data for standard loading and configure if found appropriate.
- If vendor data is not found appropriate for standard loading, creates request, with requirements definition, to data loader development group.
- Develops data point mapping, based data loader being used, and import to GSS operations data feed management system.
- Executes test data load and review results for accuracy and completeness of data point mapping.
- Remediate errors and omissions from review.
- Performs QC evaluation on data feeds mappings created by other Clinical Data Informatics Leads and/or Clinical Data Informatics Specialists.
- Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
- Essential Job Duties:
- Demonstrate the ability to multi-task and manage data feed configurations and date point mapping development.
- Plan and establish timelines to meet or exceed business expectations for data feed configurations and date point mapping development.
- QC data feed configurations and date point mappings.
- Strong troubleshooting and analytical skills for identification of errors and omissions for remediation.
- 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.
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.
- Lead or assist with special projects as designated.
- Perform other duties as assigned by management.
Bachelores degree preferably in the sciences or related field, or two (2) years in a data analysis and/or profiling position.
- Minimum 2 years data informatics 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.
- 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 DEForge or Navicat, preferred.
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