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Senior Clinical Database Designer I
Everest Clinical Research. Design clinical databases for new studies in various electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coder, and RTSM .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical database design and management, with a strong focus on EDC systems such as Inform, iDatafax/DFdiscover, Clinical One, and Medidata Rave. Proven ability to lead projects, ensure compliance with regulatory standards, and effectively communicate with diverse stakeholders.
Highest-signal resume keywords
Clinical Database DesignEDC Systems (Inform, iDatafax/DFdiscover, Clinical One, Medidata Rave)Data Management ProceduresRegulatory ComplianceProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Database DesignUnit TestingIntegration TestingImpact AssessmentData IntegrationDatabase ModificationsStudy Design SpecificationsQuality Control AuditsReal-Time Monitoring ReportsStudy Decommissioning
Soft Skills
Effective CommunicationLeadership SkillsInterpersonal SkillsPresentation SkillsOrganizational Skills
Certifications & Qualifications
Sc. in Biological SciencesSc. in Computer Science
Industry Keywords
Clinical Data ManagementElectronic Data Capture (EDC)Best Practices in Data ManagementStudy-Level EfficiencyBenchmarking
About the role
Key responsibilities & impact- Design clinical databases for new studies in various electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coder, and RTSM
- Perform post-go-live database modifications and provide impact assessments
- Perform unit testing, assist user acceptance testing, and address UAT findings
- Set up and configure development environments for new studies
- Assist with Database Integration Specifications, provide Integration Technical Details, program integrations, and assist integration testing
- Support Data Managers in investigating and addressing database design issues
- Assist study decommissioning and archiving
- Develop database design features and functionality to improve study-level efficiency and company capabilities
- Review study design specifications for EDC platform and Everest standards compliance
- Review protocols and reference materials to ensure database design specifications meet protocol requirements
- Contribute to database design project timelines and maintain database design timelines
- Assist Clinical Data Management in planning, directing, and managing database design and maintenance
- Follow regulatory requirements, industry trends, benchmarking, and best practices in data management and database design
- Participate in EDC vendor technical learning and exchange meetings and other training meetings
- Contribute to database design procedures, work instructions, checklists, and templates
- Provide input to database design-related data management procedures
- Cooperate with Quality Assurance on quality control audits
- Validate and disseminate real-time study monitoring reports to sponsors and internal team members
- Participate in Clinical Data Management initiatives
Requirements
What you’ll need- Sc. in Biological Sciences or Computer Science
- Five years’ related experience
- Two to three years developing Inform, iDatafax/DFdiscover, Clinical One and/or Medidata Rave (or similar) clinical databases
- Effective oral and written communication with personnel on all professional and administrative levels
- Proven leadership and interpersonal skills in complex team situations
- Excellent presentation skills and ability to build relationships with internal and external clients
- Well-organized, able to work independently, and able to manage multiple projects/tasks appropriately
- Ability to effectively organize and integrate the activities of information processing personnel
Benefits
Comp & perks- Remote work from a home-based office in accordance with the Work from Home policy