Clinical Database Designer I

Role Description

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Clinical Database Designer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy.

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems, including:
  • Case Report Forms (CRF)
  • Edit checks
  • Study roles
  • Laboratory
  • Coder
  • Randomization and Trial Supply Management (RTSM)
• Perform post go-live changes (database modifications) based on updated requirement specifications 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 adherence to EDC platform standards and Everest Standards, including:
  • CRF and Visit Map specification
  • Data Validation Specification (DVS)
  • 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.
• 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

• 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)
• 401(k) retirement plan
• Generous paid time off and sick leave
• Opportunity to earn a performance-based bonus

Company Description

Everest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.