Clinical Trial Data Manager

2 days ago

Jamnagar, Gujarat, India beBeeClinicalDataManagement Full time ₹ 60,00,000 - ₹ 80,00,000

Clinical Data Management Specialist Position Overview

This is a critical role in managing clinical trial data from external sources, ensuring its accuracy and relevance.

Main Responsibilities:

  • Develop project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools.
  • Familiarize yourself with external data collection, its integration into the clinical trial, and management and reconciliation processes to ensure data quality.
  • Implement data cleaning strategies to accelerate time to achieve subject data cleanliness and deliver high-quality results.
  • Perform comprehensive 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 efficiency and quality of trial data.
  • Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study leads/project managers.
  • Manage Query Resolution.
  • Define specifications and collaborate with technical teams on configuration of centralized data management platforms, elluminate Data Central for data cleaning strategy and oversight activities.
  • Maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout the trial lifecycle.
  • Review and ensure quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Evaluate and contribute to enhance processes to increase efficiency and effectiveness.
  • Collaborate and work as a team to ensure deliverables are completed on time with high quality.
  • Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
  • Other duties as assigned.

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