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Senior Clinical Database Designer
Everest Clinical Research. Develop new features and functionality within database design functional areas .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management, including database design, electronic data capture systems, and regulatory compliance. Proficient in developing and reviewing Data Validation Specifications, User Acceptance Test plans, and managing clinical trial data flow.
Highest-signal resume keywords
Clinical Data ManagementDatabase DesignElectronic Data Capture SystemsSAS ProgrammingUser Acceptance Testing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Database DesignData Validation SpecificationsUser Acceptance TestingSAS ProgrammingClinical Trial Data FlowCase Report Forms DesignData Processing ActivitiesQuery ResolutionQuality Control AuditsData Management Plans
Soft Skills
Effective CommunicationLeadership SkillsInterpersonal SkillsPresentation SkillsOrganizational Skills
Tools & Technologies
InformMedidata RaveElectronic Data Capture SystemsDataflow
Industry Keywords
Clinical TrialsRegulatory RequirementsBest Practices in Data ManagementBenchmarkingQuality Control Processes
About the role
Key responsibilities & impact- Develop new features and functionality within database design functional areas
- Assist Clinical Data Management with planning, directing, and managing clinical database design and maintenance
- Review protocols and study reference materials to contribute to database design project timelines
- Maintain database design timelines and promote good project management practices
- Follow regulatory requirements, industry trends, benchmarking, and best practices in data management and database design
- Design and review case report forms (CRFs/eCRFs) and set up electronic data capture (EDC) systems for clinical trials
- Author and review Data Validation Specifications
- Develop and review User Acceptance Test (UAT) plans
- Coordinate and oversee UAT processes
- Design and review patient case report forms and database schemas
- Test data capture and entry screens through UAT
- Participate in EDC vendor technical learning and exchange meetings and training meetings
- Participate in Investigators Meetings and provide user training to CRAs on EDC systems, Dataflow, and Quality Control Processes
- Contribute to database design procedural documents, work instructions, checklists, and templates
- Provide input to data management procedural documents
- Plan, manage, control, and perform data processing activities for assigned projects
- Review Data Management Plans
- Review data and issue and resolve queries
- Assist Lead Data Manager, sponsors, or investigative sites with query resolution
- Assist in resolving medical coding discrepancies
- Assist Quality Assurance with quality control audits
- Validate and disseminate real-time study monitoring reports
- Define and monitor clinical trial data flow and quality control processes
- Validate electronically captured data
- Write queries for missing data and data failing range or logical checks
- Participate in Clinical Data Management initiatives
- Develop and test SAS code for clinical trial database logical checks and study-specific monitoring reports
Requirements
What you’ll need- B.Sc. in Biological Sciences or Computer Science
- Five years' related experience
- Two to three years developing Inform and/or Medidata Rave (or similar) clinical databases
- Previous Clinical Data Management experience in both paper-based and electronic data capture systems
- Effective oral and written communication with personnel at 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- Medical, dental, and vision coverage
- Life & AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- Pension plan
- Generous paid time off and sick leave
- Opportunity to earn a performance-based bonus
- Remote work from a home-based office anywhere in Canada in accordance with the Work from Home policy