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Keywords / Skills : data informatics, Clinical Data Management, Data Validation, Data Reconciliation, Database Programming, SQL, Excel, Pivots, Lookups, RDBMS

2 - 4 years
Posted: 2019-05-07

Job Description
Job Overview:
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.

Job Summary:
  • 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:
Function Specific
  • 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.
  • 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.
  • External: None

Education/Qualifications:

BS/BA degree preferably in the sciences or related field, or two (4) years in a data analysis and/or profiling position.
Experience:

  • Minimum 2 years to 4 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.


About Company

Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.
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