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Senior Clinical Database Designer II
Everest Clinical ResearchSenior Clinical Database Designer II developing clinical databases for Everest, a CRO based in Warsaw. Involves design, testing, quality control, and mentoring others.
ATS Keywords
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Hard Skills
database designunit testingquality controlintegration testingdata managementproject managementdatabase modificationsclinical database developmentEDC systemsregulatory compliance
Soft Skills
effective communicationleadershipinterpersonal skillspresentation skillsorganizational skillsindependent workrelationship buildingteam collaborationproblem-solvingmentoring
Tools & Technologies
InformDFdiscoverClinical OneMedidata Raveelectronic data capture (EDC)Everest Standardsdatabase integration specificationdevelopment environmentQC auditsreal-time study monitoring
Certifications & Qualifications
B.Sc. in Biological SciencesB.Sc. in Computer Science
Industry Keywords
clinical data managementbest practicesstudy decommissionarchivingproject timelinestrainingbenchmarkingprocedural documentschecklistsguides
About the role
Key responsibilities & impact- Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems.
- Perform post go-live changes (database modifications) based on updated requirement specifications in various EDC systems, provide impact assessment for modifications.
- Perform unit testing on the database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
- Perform quality control (QC) review of databases designed by other designers.
- Set-up and configure the development environment for new studies.
- Assist with the creation of the Database Integration Specification with other systems, provide Integration Technical Detail as needed, program and assist with the integration and testing.
- Support the Data Manager in investigating and addressing issues related to the database design.
- Assist with study decommission and archiving.
- Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study-level and to improve and enhance the company’s database design capabilities.
- Mentor and provide guidance to new Database Designers on the procedures and best practices related to the database design.
- Review study design requirement specifications, ensuring the specifications adhere to EDC platform standards and Everest Standards with best design practice.
- Contribute to the development of database design project timelines.
- Maintain database design timelines and promote good project management practices.
- Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading and participating in relevant training and/or relevant association activities.
- Participate in EDC vendor’s technical learning and exchange meetings and other internal and external training meetings.
- Develop and maintain the company’s database design procedural documents, Work Instructions, checklists, guides, and templates for all EDC systems.
- Provide input to all database design-related data management procedural documents.
- Cooperate with and assist the Quality Assurance department with QC audits on assigned databases.
- Validate and disseminate real-time study monitoring reports to the Sponsor and internal team members.
- Participate in and contributes to Clinical Data Management initiatives.
Requirements
What you’ll need- B.Sc. in Biological Sciences or Computer Science
- Five years’ related experience
- Two to three years developing Inform, 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 and 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- Flexible work arrangements
- Professional development opportunities