- Assist in preparing clean databases by reviewing clinical trial data through CDMS or external data listings
- Ensure captured data follows protocol and Data Management Plan rules
- Provide input to and review Data Management Plans for clinical study deliverables
- Generate queries to internal or external personnel to resolve problematic data
- Review query responses, resolve discrepancies, and modify databases accordingly
- Support development of CRFs and edit check specifications per protocol
- Participate in user acceptance testing of CRFs, edit check specifications, and study-specific data listings
- Prepare and maintain documentation for CRF, edit check, and data listing testing
Requirements
- Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience
- 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (e.g., Oracle RDC/Inform, Medidata Rave, DataLabs, etc.); alternatively, proven experience in all primary job functions
- Excellent English verbal and written communication skills
- Excellent computer skills in a Microsoft Windows environment
- Proficiency in Microsoft Office Suite tools (e.g., Outlook, Word, Excel, etc.)
- Proven ability to drive a successful customer experience through positive customer interactions, quality and timely deliverables, and task ownership
- Strong analytical and organizational skills
- Ability to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Core Competencies
Demonstrates expertise in clinical data management, including proficiency in commercial clinical data management systems and EDC products, while ensuring compliance with protocols and data management plans. Strong analytical, organizational, and communication skills are essential for managing multiple projects and delivering quality results.
Highest-signal resume keywords
- Clinical Data Management
- EDC Products
- Data Management Plans
- Analytical Skills
- Communication Skills
ATS Optimization Keywords
Hard Skills
- Clinical Trial Data Review
- Database Management
- Query Generation
- CRF Development
- User Acceptance Testing
Soft Skills
- Organizational Skills
- Customer Experience Management
- Independence
- Task Ownership
Industry Keywords
- Clinical Trials
- Data Management
- Data Integrity
- Protocol Compliance
Tools & Technologies
- Oracle RDC/Inform
- Medidata Rave
- DataLabs
- Microsoft Office Suite