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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.
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
database designunit testinguser acceptance testingintegration programmingdata managementcase report formsedit checksdatabase modificationsimpact assessmentproject management
Soft Skills
effective communicationleadershipinterpersonal skillspresentation skillsorganizational skillsindependent workmulti-taskingrelationship building
Tools & Technologies
InformiDatafaxDFdiscoverClinical OneMedidata Raveelectronic data capture systemsdevelopment environment
Certifications & Qualifications
B.Sc. in Biological SciencesB.Sc. in Computer Science
Industry Keywords
clinical databaseregulatory requirementsbest practicesclinical data managementdatabase integration specification
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