Everest Clinical Research (“Everest”) is a full-service 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’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
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.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Clinical Database Designer II 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 not limited to, case report forms (CRF), edit checks, study roles, laboratory, coder, RTSM.
- Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems, provide impact assessment for modifications.
- Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, address UAT findings.
- Setup 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 Data Manager (DM) in investigating and addressing issues related to the database design.
- Assist study decommission and archiving.
- Review study design requirement specifications for assigned projects, ensuring the specifications adhere to EDC platform standards and Everest Standards with best design practice. Specification includes, but not limited to, 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 by reading, participating in relevant training, and/or association 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 procedural documents, work instructions, checklists, and templates for all EDC systems.
- Contribute to the development and maintenance of the company’s database design standard libraries for all EDC systems.
- Contribute to the development and maintenance of the company’s database design guidelines for all EDC systems.
- Provide input to all database design-related data management procedural documents.
- Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team members.
- Participate in and contributes to Clinical Data Management initiatives. Design and program tools to assist database design tasks and DM tasks.
Qualifications
- B.Sc. in Biological Sciences or Computer Science.
- One to two years of clinical database design experience, such as developing clinical databases in iDatafax/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.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com
We thank all interested applicants, however, only those selected for an interview will be contacted.
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.
