Clinical Data Management Specialist

9 hours ago

bangalore, India ACL Digital Full time

Responsibilities:



  • Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools.
  • Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
  • Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies.
  • Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the 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 lead(s)/project manager.
  • Perform Query Management.
  • Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities.
  • Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
  • 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.
  • Collaborate and work as a team to ensure the 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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