Clinical Database Designer I, Markham

We are seeking a committed, skilled, and customer-focused individual to join our winning team as

Clinical Database Designer

for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

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.

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.

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), pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $50,000 - $100,000.

EEO Statement Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

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