Clinical Data Management With Oracle Clinical Training
The goal of Clinical Data Management (CDM) with Oracle Clinical Training is to instruct participants in efficiently using Oracle’s specialist software for managing clinical trial data. This program covers data collection, validation, database design, data analysis, and guaranteeing regulatory compliance in clinical research. The objective is to guarantee the accuracy, completeness, and security of clinical trial data throughout a clinical study.
- 10+ Courses
- 30+ Projects
- 400 Hours
Clinical Data Management With Oracle Clinical Training is suitable for the following target audiences:
Clinical Data Managers: Experts who want to learn more about Oracle Clinical and are in charge of handling and supervising data in clinical trials.
Clinical Research Associates (CRAs): Clinical Research Associates (CRAs) are researchers and clinical trial participants who want to improve their Oracle Clinical data management abilities.
IT and Database Administrators in Healthcare and Pharmaceuticals: IT specialists who support clinical data management systems in the healthcare and pharmaceutical industries.
Clinical Trial Coordinators/Managers: Clinical trial managers and coordinators oversee clinical studies and must know data management procedures and legal requirements.
Regulatory Affairs Specialists: Experts who ensure clinical data standards and regulations are followed and who wish to advance their technical understanding of clinical data administration.
Clinical Data Manager: Supervising and controlling data gathering from clinical trials while guaranteeing precision and adherence.
Clinical Database Programmer: Create and manage clinical trial databases using Oracle Clinical software.
Clinical Research Data Analyst: Examining and evaluating clinical trial data for reporting and decision-making in biotech and pharmaceutical firms.
Clinical Research Coordinator: overseeing clinical trial operations and data management while maintaining regulatory compliance.
Regulatory Compliance Specialist: Making sure clinical data complies with rules and regulations.
In the USA and Canada, these positions are highly sought after in industries like biotechnology, pharmaceuticals, clinical research organizations (CROs), and healthcare. Due to the increased focus on clinical trials and data accuracy, there are excellent opportunities for professional advancement in these areas.
- Overview of clinical trials and drug development phases
- Role of data management in clinical studies
- Key stakeholders in clinical research
- Introduction to Clinical Data Management processes
- Regulatory environment and compliance basics
- Case Report Forms (CRFs) and electronic CRFs
- Data sources in clinical trials
- Designing CRFs for accurate data capture
- Data collection workflow
- Practical: Create a simple CRF for a mock clinical study.
- Clinical database design principles
- Data fields, validation rules, and edit checks
- Introduction to Electronic Data Capture (EDC) systems
- Data standards and structures
- Practical: Design a basic clinical trial database structure.
- Data entry procedures
- Data cleaning and validation methods
- Query management
- Identifying missing or inconsistent data
- Practical: Perform query generation and resolution exercises.
- Introduction to CDISC standards
- Study Data Tabulation Model (SDTM) basics
- Data form
- Data quality control
- Good Clinical Data Management Practices (GCDMP)
- Regulatory requirements in clinical trials
- Data integrity and audit trails
- Introduction to Good Clinical Practice
- Hands On: Review data logs and perform quality checks.
- Database lock procedures
- Preparing data for statistical analysis
- Data transfer to biostatistics teams
- Clinical study reports and documentation
- Practical: Simulate database lock and prepare a dataset for analysis.
- Overview of clinical data management software tools
- Integration with biostatistics and pharmacovigilance
- Career path guidance in clinical research
- Final Project: Manage the full data lifecycle of a simulated clinical study from data collection to database lock.
It is the process of collecting, cleaning, and managing data generated during clinical trials.
Life sciences graduates, clinical research professionals, data analysts, and healthcare researchers.
A background in life sciences, pharmacy, or healthcare is helpful but not always required.
Electronic Data Capture (EDC) systems and clinical database platforms are commonly used.
Global standards from organizations like Clinical Data Interchange Standards Consortium and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
It is a global organization that develops data standards for clinical research.
It is the final step where the clinical database is closed and prepared for statistical analysis.
Yes, students work with sample clinical datasets and CRF designs.
Roles such as clinical data manager, clinical research associate and clinical data analyst.
Most training institutes provide a completion certificate for Clinical Data Management training.
We currently offer online sessions with flexible weekday/weekend batches for 8 weeks. All sessions are recorded. You’ll have access to the recordings, along with support from instructors and peers in our learning portal.
You can register via our website https://checkmateittech.com/, or reach out to our support teams via phone, email, or WhatsApp. We’ll help you with batch schedules and payment options.
Email info@checkmateittech. Call Us at +1-347-408-2054.
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Job opportunities in USA and Canada
Clinical Data Manager: Supervising and controlling data gathering from clinical trials while guaranteeing precision and adherence.
Clinical Database Programmer: Create and manage clinical trial databases using Oracle Clinical software.
Clinical Research Data Analyst: Examining and evaluating clinical trial data for reporting and decision-making in biotech and pharmaceutical firms.
Clinical Research Coordinator: overseeing clinical trial operations and data management while maintaining regulatory compliance.
Regulatory Compliance Specialist: Making sure clinical data complies with rules and regulations.
In the USA and Canada, these positions are highly sought after in industries like biotechnology, pharmaceuticals, clinical research organizations (CROs), and healthcare. Due to the increased focus on clinical trials and data accuracy, there are excellent opportunities for professional advancement in these areas.
