Clinical Data Integrity Specialist

4 hours ago

Madurai, Tamil Nadu, India beBeeDataGovernance Full time ₹ 10,50,000 - ₹ 14,16,000

As a seasoned Clinical Data Management Specialist, you will be responsible for ensuring the accuracy and quality of clinical trial data. Your expertise in defining project specifications, understanding external data collection, and executing data cleaning strategies will be instrumental in driving success.

Key Responsibilities:
  • Data Governance: Develop comprehensive project specifications for Data Management services, encompassing Protocol Conversion, Database Build, CRF Design, and Data Review and Reconciliation tools to guarantee data integrity.
  • External Data Integration: Collaborate with cross-functional teams to integrate external data collection seamlessly into the clinical trial process, ensuring accuracy, relevance, and adherence to regulatory requirements.
  • Advanced Analytics: Apply sophisticated data cleaning strategies to accelerate time-to-cleanliness and ensure high-quality, timely deliverables. Utilize artificial intelligence (AI) and machine learning (ML) to detect anomalies and outliers, enhancing data efficiency and quality.
  • Reporting and Insights: Conduct holistic data review and trending analysis via advanced reporting and analytics to proactively identify issues, risks, and develop mitigation strategies. Monitor key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study leads/project managers.
  • Documentation and Quality Assurance: Maintain accurate and up-to-date data management documentation (e.g., DMP, CCGs, Help Text, DVS) throughout the trial lifecycle. Ensure compliance with regulatory standards and internal policies.
  • Collaboration and Communication: Foster a collaborative environment, working closely with cross-functional teams to ensure deliverables are completed on time with high quality. Effectively communicate project status, progress, and challenges to stakeholders.

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