Clinical Database Designer I

Key Accountabilities

• 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.
• Aid in 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.
• 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.

Qualifications and Experience

• 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 & Compensation

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $50,000 - $90,000.