Clinical Database Designer I

Everest Clinical Research is a global contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. They are seeking a Clinical Database Designer I to design clinical databases for new studies, perform modifications, and support the Data Manager in addressing database-related issues.

Responsibilities

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems. Design includes, but is not limited to, Case Report Forms (CRF), edit checks, study roles, laboratory, coder, and Randomization and Trial Supply Management (RTSM)
• Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems and provide impact assessment for modifications
• Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings
• Set up 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 the Data Manager in investigating and addressing issues related to the database design
• Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest Standards. Specification includes, but is not limited to, CRF and Visit Map specification, Data Validation Specification (DVS), and Role Configuration Specification (RCS)
• Review the protocol and associated reference material and contribute to the development of the database design project timeline. 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, benchmarking, and best working practices in data management and database design by reading, participating in relevant training, and/or associated activities
• Participate in EDC vendor’s technical learning and exchange meetings, as well as other internal and external training meetings
• Contribute to the development and maintenance of the company’s database design standard libraries for all EDC systems
• Provide input to all database design-related data management procedural documents
• Cooperate with and assist the Quality Assurance (QA) Department with QA audits on assigned databases. Validate and disseminate real-time study monitoring reports to Sponsor and internal team members
• Participate in and contribute to Clinical Data Management initiatives. Design and program tools to assist database design tasks and data management tasks

Skills

• B.Sc. in Biological Sciences or Computer Science
• One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC systems
• Software programming experience relevant to the programming languages and design applications in use in clinical research
• Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels
• Excellent interpersonal skills in complex team situations, including the ability to build relationships with both internal and external clients
• Demonstrated ability to effectively organize and integrate the activities of information processing personnel
• Must be well-organized and able to work independently and manage multiple projects/tasks appropriately

Benefits

• 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

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