Clinical Data Expert

1 day ago

Vijayawada, Andhra Pradesh, India beBeeDataManagement Full time ₹ 90,00,000 - ₹ 1,20,00,000

Overview:

  • We are seeking a skilled professional to join our team as a Clinical Data Management Specialist.

About the Role:

  • This is an exciting opportunity for a motivated and detail-oriented individual to take on a challenging role in data management.
Key Responsibilities:
  • Data Management Services: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
  • Data Integration and Management: 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 Strategies: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Trending Analysis: Perform holistic data review and trending analysis via reporting and analytics to proactively identify issues, risks, and develop mitigation strategies.
  • Artificial Intelligence and Machine Learning: Utilize AI and ML for anomaly and outlier detection to enhance the efficiency and quality of trial data.
  • Performance Monitoring: Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager.
  • Query Management: Perform Query Management.
  • Data 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.
  • Data 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. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness.
  • Team 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.
  • Additional Responsibilities:
    • Other duties as assigned.

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