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Everest Clinical Research
Everest Clinical Research
501 – 1000 Darbinieki
H1B vīzas sponsorsKonsultācijasLoģistikaVeselības aprūpe
Everest Clinical Research ir globāla līgumklīnisko pētījumu organizācija, kas farmācijas un biotehnoloģiju pasūtītājiem nodrošina visaptverošu atbalstu klīnisko pētījumu veikšanā. Tās darbības jomas ietver klīniskās operācijas un projektu vadību, uz risku balstītu kvalitātes pārvaldību, centralizētu monitoringu, medicīnisko monitoringu, farmakovigilanci, klīnisko datu pārvaldību, biostatistiku, statistisko programmēšanu, regulatīvo stratēģiju un iesniegumu sagatavošanu un iesniegšanu. Uzņēmums nodrošina arī klīnisko tehnoloģiju risinājumus, tostarp IRT/RTSM un ePRO/eCOA, kā arī tam ir terapeitiskā kompetence onkoloģijā, neiroloģijā, elpceļu slimību, reto slimību un imunoloģijas jomā.
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Vakances uzņēmumā

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.

TWTaivānaAttālinātiPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuDizainers

Apraksts

  • 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

Prasības

  • 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

Priekšrocības

  • 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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