Senior Clinical Database Designer II

Senior Clinical Database Designer II

Brightech is a leading CRO that specializes in complex, value-add biostatistics, programming, and clinical data management services. Brightech, an Everest Clinical Research Company, has earned a highly-regarded reputation as a critical partner for some of the world's largest pharmaceutical and biotech companies. 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 also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company's substantive experience and infrastructure across 14 countries in Western and Eastern Europe. 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 Senior Clinical Database Designer II for our Brightech location in Taipei, Taiwan, with opportunities to work remotely from a home-based office in accordance with our Work from Home policy.

JOB ACCOUNTABILITIES:

1. 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 (CRFs), edit checks, study roles, laboratory, coder, and randomization and trial supply management.
2. Perform post go-live changes (database modifications) based on updated requirement specifications in various EDC systems, provide impact assessment for modifications.
3. Perform unit testing on the database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
4. Perform quality control (QC) review of databases designed by other designers.
5. Set-up and configure the development environment for new studies.
6. Assist with the creation of the Database Integration Specification with other systems, provide Integration Technical Detail as needed, program and assist with the integration and testing.
7. Support the Data Manager in investigating and addressing issues related to the database design.
8. Assist with study decommission and archiving.
9. Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study-level and to improve and enhance the company's database design capabilities.
10. Mentor and provide guidance to new Database Designers on the procedures and best practices related to the database design.
11. Review study design requirement specifications, ensuring the specifications adhere to EDC platform standards and Everest Standards with best design practice. Specifications include, but are not limited to, CRF and Visit Map specification, Data Validation Specifications, and Role Configuration Specifications.
12. Review the protocol and associated reference material to ensure that the study design specifications meet the protocol requirements. Contribute to the development of database design project timelines. Maintain database design timelines and promote good project management practices.
13. Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
14. Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading and participating in relevant training and/or relevant association activities.
15. Participate in EDC vendor's technical learning and exchange meetings and other internal and external training meetings.
16. Develop and maintain the company's database design procedural documents, Work Instructions, checklists, guides, and templates for all EDC systems.
17. Provide input to all database design-related data management procedural documents.
18. Cooperate with and assist the Quality Assurance department with QC audits on assigned databases. Validate and disseminate real-time study monitoring reports to the Sponsor and internal team members.
19. Participate in and contributes to Clinical Data Management initiatives.

QUALIFICATIONS:

1. Sc. in Biological Sciences or Computer Science.
2. Five years' related experience.
3. Two to three years developing Inform, DFdiscover, Clinical One and/or Medidata Rave (or similar) clinical databases.
4. Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
5. Proven leadership and interpersonal skills in complex team situations.
6. Excellent presentation skills and the ability to build relationships with both internal and external clients.
7. Must be well-organized and able to work independently and manage multiple projects/tasks appropriately.
8. Demonstrated ability to effectively organize and integrate the activities of information processing personnel.