Clinical Data Insights Specialist

2 days ago

Tiruchi, Tamil Nadu, India beBeeDataManagement Full time ₹ 15,00,000 - ₹ 25,00,000

Job Overview

The Clinical Data Management Specialist plays a pivotal role in defining project specifications, understanding external data collection, executing data cleaning strategies, and performing holistic data review and trending analysis. This position requires strong analytical skills and the ability to work collaboratively as part of a team.

Main Responsibilities

  • Data Management: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
  • Data Integration: Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
  • Data Cleaning: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Data Analysis: Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks and develop mitigation strategies.
  • AI and ML: Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data.
  • KPIs and Metrics: Monitor and interpret key performance indicators (KPIs), metrics, dashboards, and reports to provide actionable recommendations to study lead(s)/project manager.
  • Query Management: Perform Query Management.
  • Platform Configuration: Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities.
  • Documentation: Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
  • Quality Control: Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules.
  • Collaboration: Collaborate and work as a team to ensure the deliverables are completed on time with high quality.
  • Compliance: Ensure compliance with industry quality standards, regulations, guidelines, and procedures.

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