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.
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Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems, including:
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Case Report Forms (CRF)
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Edit checks
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Study roles
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Laboratory
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Coder
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Randomization and Trial Supply Management (RTSM)
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Perform post go-live changes (database modifications) based on updated requirement specifications and provide impact assessment for modifications.
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Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
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Set up and configure the development environment for new studies.
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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.
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Support the Data Manager in investigating and addressing issues related to the database design.
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Review study design requirement specifications for assigned projects, ensuring adherence to EDC platform standards and Everest Standards, including:
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CRF and Visit Map specification
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Data Validation Specification (DVS)
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Role Configuration Specification (RCS)
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Review the protocol and associated reference material and contribute to the development of the database design project timeline.
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Maintain database design timelines and promote good project management practices.
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Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
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Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design.
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Participate in EDC vendor’s technical learning and exchange meetings, as well as other internal and external training meetings.
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Contribute to the development and maintenance of the company’s database design standard libraries for all EDC systems.
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Provide input to all database design-related data management procedural documents.
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Cooperate with and assist the Quality Assurance (QA) Department with QA audits on assigned databases.
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Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.
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Participate in and contribute to Clinical Data Management initiatives.
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Design and program tools to assist database design tasks and data management tasks.
Qualifications
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B.Sc. in Biological Sciences or Computer Science.
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One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC systems.
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Software programming experience relevant to the programming languages and design applications in use in clinical research.
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Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
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Excellent interpersonal skills in complex team situations, including the ability to build relationships with both internal and external clients.
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Demonstrated ability to effectively organize and integrate the activities of information processing personnel.
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Must be well-organized and able to work independently and manage multiple projects/tasks appropriately.
Benefits
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Medical, dental, and vision coverage
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Life & AD&D insurance
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Short- and long-term disability
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Tuition reimbursement
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Fitness reimbursement
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Employee assistance program (EAP)
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401(k) retirement plan
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Generous paid time off and sick leave
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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.