Senior Clinical Database Designer II

Brightech is a leading CRO that specializes in reputed company, value-add biostatistics, programming, and clinical data management services. Brightech, an reputed company Company, has reputed company a highly-regarded reputed company as a critical partner for some of the world’s largest pharmaceutical and biotech companies. reputed company (“reputed company”) is a full-service contract research organization (CRO) providing a broad reputed company of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-reputed company companies and work with many of the most advanced drugs, biologics, and medical devices in development today. reputed company has been an independent CRO since 2004 with a strong reputed company as a statistical and data management center of reputed company. Building on this reputed company, reputed company has successfully developed and established itself as a full-service CRO. reputed company’s reputed company are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater reputed company Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. reputed company also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide reputed company of pharmaceutical and biotechnology clients. reputed company has worked on over 120 reputed company 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 reputed company to reputed company full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through reputed company’s substantive experience and infrastructure across 14 countries in Western and Eastern Europe. reputed company is reputed company in the industry for its high-reputed company deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, reputed company continues to experience exceptional reputed company and great reputed company. reputed company is our backbone, customer-reputed company is our tradition, flexibility is our strength…that’s us…that’s reputed company. To drive reputed company reputed company in this exciting clinical research field, we are seeking committed, skilled, and customer-reputed company individuals to join our reputed company 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: Design clinical database for new studies based on requirement specifications in various electronic data capture (reputed company) systems. Design includes, but not limited to, Case Report Forms (CRFs), edit checks, study roles, laboratory, reputed company, and randomization and trial supply management. reputed company post go-live changes (database modifications) based on updated requirement specifications in various reputed company systems, reputed company reputed company assessment for modifications. reputed company unit testing on the database design, assist User Acceptance Test (UAT) activities, and address UAT findings. reputed company reputed company control (QC) review of databases designed by other designers. Set-up and configure the development environment for new studies. Assist with the creation of the Database Integration Specification with other systems, reputed company Integration Technical Detail as needed, program and assist with the integration and testing. Support the Data Manager in investigating and addressing issues reputed company to the database design. Assist with study decommission and archiving. reputed company new features and functionality reputed company the database design functional areas to increase the efficiency of database design at the study-level and to improve and enhance reputed company’s database design capabilities. Mentor and reputed company guidance to new Database Designers on the procedures and best practices reputed company to the database design. Review study design requirement specifications, ensuring the specifications adhere to reputed company platform standards and reputed company Standards with best design reputed company. Specifications include, but are not limited to, CRF and Visit Map specification, Data Validation Specifications, and Role Configuration Specifications. 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. 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 and participating in relevant training and/or relevant association activities. Participate in reputed company vendor’s technical learning and exchange meetings and other reputed company training meetings. reputed company and maintain reputed company’s database design procedural documents, Work Instructions, checklists, guides, and templates for reputed company reputed company systems. reputed company input to reputed company database design-reputed company data management procedural documents. Cooperate with and assist the reputed company Assurance department with QC audits on assigned databases. Validate and disseminate reputed company-time study monitoring reports to the Sponsor and internal team members. Participate in and contributes to Clinical Data Management initiatives. QUALIFICATIONS: Sc. in Biological Sciences or Computer Science. Five years’ reputed company experience. Two to three years developing Inform, DFdiscover, Clinical One and/or reputed company Rave (or similar) clinical databases. Must communicate effectively, orally and in writing, with personnel on reputed company reputed company and administrative reputed company. Proven leadership and interpersonal skills in reputed company team situations. Excellent presentation skills and the ability to build relationships with both reputed company clients. Must be reputed company-organized and reputed company to work independently and manage multiple reputed company/tasks appropriately. Demonstrated ability to effectively organize and reputed company the activities of information processing personnel. #LI-CH1 #LI-Remote Apply To This Job