Clinical Data Manager Jobs in Irvine, CA
A Clinical Data Manager in the biotechnology industry is responsible for the collection, integration, and validation of clinical trial data. They develop data collection systems, manage databases, perform data quality checks, and ensure regulatory compliance. They play a critical role in the trial design phase, helping to create data collection instruments that meet the research objectives. They also liaise with other professionals, such as biostatisticians and clinical research associates, to ensure that data is accurate, complete, and ready for statistical analysis. They also handle data security and confidentiality issues.
Key skills for this role include strong analytical abilities, attention to detail, proficiency in database management, and a firm grasp of clinical trial processes and regulations. A Clinical Data Manager should have familiarity with Clinical Data Interchange Standards Consortium (CDISC) standards and be proficient in the use of Electronic Data Capture (EDC) systems. Certifications such as Certified Clinical Data Manager (CCDM) can further attest to their competency. Prior roles that can lead to a Clinical Data Manager position might include Clinical Data Coordinator, Database Administrator, or Clinical Research Associate.
, including roles in clinical data management and/or clinical data entry....
Review and provide input to clinical data management deliverables including, but not limited to, the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications...
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Salary for Clinical Data Manager Jobs in Irvine, CA
Required or preferred licenses and certifications for Clinical Data Manager positions.
Highest Education Level
Clinical Data Managers in Irvine, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Clinical Data Manager position
- Microsoft Access
- Adobe Acrobat
- Estimating
- Resolution
- Data Analytics
- Bash
- User Acceptance Testing
- Database Design
- Budgets
- Specifications
- Image Processing
- Microsoft Power BI
- TensorFlow
- Data Quality
- ICH GCP
- Institutional Review Board
- Biomarkers
- Clinical Data Management
- Proteomics
- ICH Guidelines
- Cancer Research
- Biostatistics
- Bioinformatics
- Drug Development
- Biology
- Chemical Characterization
- Epidemiology
- Hematology
- Clinical Trials
- Biotechnology
- Clinical Operations
- Clinical Research
- Validation
- Oncology
- FDA Regulations
- Medical Device Sales
- Statistical Analysis System
- Data Collection
- Standard Operating Procedures
- Data Management
- Statistics
- Computer Programming
- Affirmative Action
- Collections
- Auditing
- Written Communication
- Data Analysis
- Documentation
- Quality Assurance
- Collaboration
- Data Entry
- Bachelor's Degree
- Reporting
- Regulations
- Project Management
- Research Skills
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Staff Supervision
- Organization
- Computer Skills
- Leadership
- Communication Skills
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