Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Post : Senior Data Monitoring Coordinator
Job Summary
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.
Triages unacceptable errors for resolution.
• If error matches known error type, with known standard resolution, implement known resolution.
• Manually re-execute data load for data feeds that have had standard resolutions applied.
• For unknown errors, investigate to point of understanding resolution, or as far as possible. Escalate findings to Data Monitor Lead.
• Develop new standard monitoring scripts for unknown errors and develop standard resolutions instructions.
• 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 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.
• 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.
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Candidate Profile
• BS/BA degree preferably in the sciences or related field, or two (2) years in a data analysis and/or profiling.
• Minimum 6 months to 2 years 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.
Additional Information
Experience : 6 months to 2 years
Qualification : BS/BA degree
Location : Bangalore
Industry Type : Pharma
Functional Area : Data Monitoring
End Date : 30th May, 2019
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