
Senior Data Management Specialist
5 days ago
Overview:
The Clinical Data Management Specialist is responsible for defining project specifications, managing data quality, and overseeing the entire clinical trial process.
Key Responsibilities:
- Data Management Services: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design, and Data Review and Reconciliation tools.
- Data Integration and Reconciliation: Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
- Quality Control: Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
- Reporting and Analytics: 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.
- Centralized Data Management Platform: 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 Management Documentation: Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
- Quality Control of Deliverables: 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.
- Process Improvement: 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.
What We Offer:
- A dynamic and collaborative work environment.
- Ongoing training and professional development opportunities.
- A competitive compensation package.
How to Apply:
Apply now by sending your resume and cover letter to us. We look forward to hearing from you
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