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Everest Clinical Research
Everest Clinical Research
501 – 1 000 Darbuotojai
H1B vizos rėmėjasKonsultavimasLogistikaSveikatos priežiūra
„Everest Clinical Research“ yra pasaulinė sutartinių klinikinių tyrimų organizacija, teikianti farmacijos ir biotechnologijų užsakovams visapusišką klinikinių tyrimų vykdymo pagalbą. Jos veikla apima klinikines operacijas ir projektų valdymą, rizika pagrįstą kokybės valdymą, centralizuotą stebėseną, medicininę stebėseną, farmakologinį budrumą, klinikinių duomenų valdymą, biostatistiką, statistinį programavimą, reguliavimo strategiją ir paraiškų teikimą. Įmonė taip pat teikia klinikinių technologijų sprendimus, įskaitant IRT/RTSM ir ePRO/eCOA, bei turi terapinės srities kompetencijos onkologijos, neurologijos, kvėpavimo takų ligų, retų ligų ir imunologijos srityse.
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Senior Clinical Database Designer II (Taiwan Remote)

Senior Clinical Database Designer II developing and validating EDC databases for Everest Clinical Research, a global clinical research CRO. The role supports clinical trials through testing, integrations, quality control, and database standards.

TWTaivanasNuotolinisVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųDizaineris

Aprašymas

  • Design clinical databases for new studies across electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coding, randomization, and trial supply management
  • Implement post-go-live database changes and assess their impact
  • Conduct unit testing, support User Acceptance Testing, and resolve UAT findings
  • Perform quality-control reviews of databases created by other designers
  • Establish and configure development environments for new studies
  • Prepare Database Integration Specifications, supply technical integration details, and support integration testing
  • Help Data Managers investigate and resolve database design issues
  • Support study decommissioning and archival activities
  • Create database design features and functionality that improve study efficiency and organizational capabilities
  • Mentor new Database Designers on procedures and best practices
  • Review study design specifications and protocols for compliance with EDC and Everest standards
  • Contribute to and maintain database design project schedules
  • Support Clinical Data Management in planning, directing, and managing database design and maintenance
  • Track regulatory requirements, industry developments, benchmarking, and data management best practices
  • Take part in EDC vendor technical meetings and training sessions
  • Create and maintain database design procedures, work instructions, checklists, guides, and templates
  • Support Quality Assurance QC audits for assigned databases
  • Validate and distribute real-time study monitoring reports to sponsors and internal team members
  • Participate in Clinical Data Management initiatives

Reikalavimai

  • Bachelor of Science degree in Biological Sciences or Computer Science
  • Five years of relevant professional experience
  • Two to three years of experience developing clinical databases with Inform, DFdiscover, Clinical One, Medidata Rave, or a comparable platform
  • Strong oral and written communication skills for working with professionals and administrative staff at all levels
  • Demonstrated leadership and interpersonal skills in complex team environments
  • Excellent presentation abilities and relationship-building skills with internal and external clients
  • Strong organization, independence, and ability to manage multiple projects and tasks effectively
  • Ability to organize and coordinate the work of information processing personnel

Privalumai

  • Home-based remote work in line with the Work from Home policy
  • Relevant training and professional association activities
  • Technical learning and knowledge-sharing meetings with EDC vendors
  • Internal and external training sessions

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