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Senior Clinical Database Designer
Everest Clinical ResearchSenior Clinical Database Designer I at Everest CRO designing and managing clinical databases for clinical trials. Collaborating with teams to ensure compliance and efficiency in database structures.
About the role
Key responsibilities & impact- Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems
- Design includes case report forms (CRF), edit checks, study roles, laboratory, coder, RTSM
- Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems
- Provide impact assessment for modifications
- Perform Unit Testing on database design
- Assist User Acceptance Test (UAT) activities
- Address UAT findings
- Setup and configure the development environment for new studies
- Assist the creation of the Database Integration Specification (DIS) with other systems
- Provide Integration Technical Detail (ITD) as needed
- Program the integration and assist the integration test
- Support Data Manager (DM) in investigating and addressing issues related to the database design
- Assist study decommission and archiving
- Develop new features and functionality within the database design functional areas to increase efficiency
- Review study design requirement specifications
- Maintain database design timelines and promote good project management practices
- Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process
- Follow up on regulatory requirements, industry trends, and best practices by participating in training and activities
- Contribute to the development and maintenance of the company’s database design procedural documents
Requirements
What you’ll need- B.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
- Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels
- Proven leadership and interpersonal skills in complex team situations
- Excellent presentation skills and the ability to build relationships with both internal and external clients
- Must be well-organized, able to work independently, and manage multiple projects/tasks appropriately
- Demonstrated ability to effectively organize and integrate the activities of information processing personnel.
Benefits
Comp & perks- Work from Home policy
- Opportunities to work remotely
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
database designunit testinguser acceptance testingintegration programmingdata managementcase report formsedit checksdatabase modificationsimpact assessmentproject management
Soft Skills
effective communicationleadershipinterpersonal skillspresentation skillsorganizational skillsindependent workmulti-taskingrelationship building
Certifications
B.Sc. in Biological SciencesB.Sc. in Computer Science