GCC Quality Data Management Specialist

4 days ago

Bengaluru, Karnataka, India Zota Health Care Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Job Summary

The GCC Quality Data Management Specialist is responsible for overseeing the collection, validation, processing, and maintenance of pharmaceutical data, ensuring the highest standards of data quality, integrity, and compliance with global regulatory guidelines. This role is crucial for supporting accurate reporting, decision-making, and regulatory submissions.

Key Responsibilities

  • Data Collection and Management: Manage the design and implementation of data collection systems, including Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems, ensuring efficient data input, storage, and retrieval.
  • Data Integrity and Quality Control: Implement and monitor data validation checks, discrepancy management, and query resolution processes to ensure data is complete, consistent, correct, and reliable (following ALCOA+ principles).
  • Documentation and Compliance: Ensure all data management activities and documentation (SOPs, data management plans, reports, etc.) comply with internal protocols and external regulations (FDA, EMA, ICH, etc.).
  • Audits and Inspections: Participate in and support internal and external audits and inspections by regulatory authorities, providing necessary data and documentation to demonstrate compliance.
  • Collaboration and Reporting: Work closely with cross-functional teams, including clinical research, biostatisticians, and Quality Assurance, to resolve data issues, generate data summaries, and prepare detailed reports for management.
  • Process Improvement: Identify and implement process improvements for data handling, storage, and analysis, staying updated with industry best practices and technological advancements (e.g., AI/ML integration).
  • Training: Provide training and guidance to staff on data management procedures, quality standards, and system updates.

Preferred candidate profile

  • Education: Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmaceutical Sciences, Biotechnology, Computer Science).
  • Experience: Proven experience in data management or a similar role within the pharmaceutical, biotech, or clinical research industry.
  • Regulatory Knowledge: Deep understanding of pharmaceutical regulations and standards, including GCP, GMP, GLP, and CDISC standards.
  • Technical Skills: Proficiency in data management software and tools (e.g., EDC systems, SAS, SQL, Oracle Clinical, JIRA), and strong MS Office skills.
  • Soft Skills: Exceptional attention to detail, strong analytical and problem-solving abilities, excellent communication skills, and the capacity to manage multiple tasks and deadlines.

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