Senior Data Monitoring Coordinator Job in Covance India Pharmaceutical Services Private Limited

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Job Description

 

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 DutiesFunction-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 potentialimprovements 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.
• Lead or assist with special projects as designated.
• Perform other duties as assigned by management.

Education/Qualifications

• BS/BA degree preferably in the sciences or related field, or two (2) years in a data analysis and/or profiling.

Experience

• 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.

Skills Required

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