Clinical Data Governance Specialist

1 week ago

Thāne, Maharashtra, India beBeeClinicalDataManagement Full time ₹ 12,00,000 - ₹ 25,00,000
About the Role

The Clinical Data Management Specialist plays a pivotal role in ensuring the accuracy, relevance, and timeliness of clinical trial data.

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 Collection and 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 Strategies: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
  • Data Review and Trending Analysis: Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issues, risks, and develop mitigation strategies.
  • Artificial Intelligence and Machine Learning: Utilize artificial intelligence (AI) and machine learning (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.
  • 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.
Requirements
  • Technical Skills: Strong understanding of data management concepts, protocols, and technologies.
  • Soft Skills: Excellent communication, collaboration, and problem-solving skills.
  • Education and Experience: Bachelor's degree in Computer Science, Information Technology, or related field; minimum 2 years of experience in data management.
We Offer

A dynamic work environment, opportunities for professional growth, and a competitive compensation package.

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