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Senior Data Monitoring Coordinator

1.00 to 2.00 Years   Bangalore   21 May, 2019
Covance India Pharmaceutical Services Private Limited
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
Industryharma / Biotech
Functional AreaAllied Health Services
EmploymentTypeFull-time

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.

Keyskills :
biotechnologyanalyticsfdanalysisdatacollectionentrydatamanagementdatadatamappingbusinessintelligencereportingdatamonitoring

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