Clinical Data Operations Lead

1 week ago

Madurai, Tamil Nadu, India beBeeData Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title:

Clinical Data Management Specialist

Job Overview:

This role involves managing and processing clinical data for trials, ensuring accuracy, quality, and adherence to regulatory standards.

Key Responsibilities:
  • Define project specifications for data management services, including protocol conversion, database build, CRF design, and data review and reconciliation tools.
  • Understand external data collection, its integration into clinical trials, and the management and reconciliation processes required to ensure accuracy and relevance.
  • Execute data cleaning strategies to accelerate subject data cleanliness and ensure high-quality deliverables.
  • Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks, and develop mitigation strategies.
  • Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance trial data efficiency and quality.
  • Monitor and interpret key performance indicators (KPIs), metrics, dashboards, and reports to provide actionable recommendations.
  • Collaborate with technical teams to configure centralized data management platforms and ensure data quality control.
  • Maintain data management documentation and update throughout the trial lifecycle.
  • Review and ensure the quality of team-developed deliverables, covering eCRFs, study documents, and program/report specifications.
  • Collaborate as part of a team to ensure timely completion of deliverables with high quality.
  • Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
Required Skills and Qualifications:
  • Proven experience in clinical data management and analysis.
  • Strong understanding of data management principles, including data validation, cleansing, and standardization.
  • Excellent analytical, problem-solving, and communication skills.
  • Proficiency in software applications, including Excel, SQL, and programming languages.
  • Ability to work effectively in a team environment and collaborate with stakeholders.
Benefits:
  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • Collaborative and dynamic work environment.

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