
Clinical Data Management Professional
4 days ago
Clinical Data Manager
Job DescriptionWe are seeking an experienced Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for the design, implementation, and management of clinical trials.
The ideal candidate will have strong analytical and problem-solving skills, with the ability to think critically and work independently. They will also possess excellent communication and project management skills, with the ability to collaborate effectively with cross-functional teams.
Key Responsibilities:- Data Management: Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design, and Data Review and Data Reconciliation tools.
- Data Quality: Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure accuracy and relevance.
- Data Cleaning: Execute data cleaning strategies to accelerate time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
- Data Analysis: Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issues, risks, and develop mitigation strategies.
- Artificial Intelligence: Utilize AI and machine learning for anomaly and outlier detection to enhance efficiency and quality of trial data.
- Query Management: 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.
- Documentation: Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle.
- Educational Background: Bachelor's degree in a life science or related field.
- Experience: Minimum 3 years of experience in clinical data management, preferably in a pharmaceutical or biotechnology company.
- Skills: Strong knowledge of GCP, CDISC, and regulatory requirements; excellent analytical, problem-solving, and communication skills.
- Professional Growth: Opportunities for career advancement and professional growth within the company.
- Collaborative Environment: Collaborative and dynamic work environment with a team of professionals who share similar interests and values.
- Competitive Compensation: Competitive salary and benefits package.
Please note that this job description is not exhaustive and may be subject to change.
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