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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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Senior Clinical Database Designer I - Remote in Taiwan

Designs, tests, and maintains electronic data capture databases for Everest Clinical Research, a global clinical research CRO. Supports integrations, data managers, sponsors, and clinical data management initiatives.

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, and RTSM.
  • Implement post-go-live database changes and assess their impact.
  • Conduct unit testing, support user acceptance testing, and resolve UAT findings.
  • Establish and configure development environments for new studies.
  • Support Database Integration Specifications, provide Integration Technical Details, develop integrations, and assist with integration testing.
  • Help Data Managers investigate and resolve database design issues.
  • Support study decommissioning and archival activities.
  • Develop database design features and functionality that improve study efficiency and company capabilities.
  • Review study design specifications for EDC platform and Everest standards compliance.
  • Review protocols and reference materials to confirm that database design specifications meet protocol requirements.
  • Support database design project planning and maintain project timelines.
  • Assist Clinical Data Management with planning, directing, and managing database design and maintenance.
  • Follow regulatory requirements, industry developments, benchmarking practices, and data management and database design best practices.
  • Participate in EDC vendor technical learning, knowledge-exchange, and other training meetings.
  • Contribute to database design procedures, work instructions, checklists, and templates.
  • Provide input on data management procedures related to database design.
  • Collaborate with Quality Assurance on quality control audits.
  • Validate and distribute real-time study monitoring reports to sponsors and internal team members.
  • Contribute to Clinical Data Management initiatives.

Prasības

  • Sc. in Biological Sciences or Computer Science.
  • Five years of related experience.
  • Two to three years of experience developing Inform, iDatafax/DFdiscover, Clinical One, Medidata Rave, or similar clinical databases.
  • Strong oral and written communication skills for working with personnel at all professional and administrative levels.
  • Demonstrated leadership and interpersonal skills in complex team environments.
  • Excellent presentation skills and the ability to build relationships with internal and external clients.
  • Strong organizational skills, independence, and the ability to manage multiple projects and tasks effectively.
  • Ability to organize and integrate the activities of information processing personnel effectively.

Priekšrocības

  • Remote work from a home-based office in accordance with the Work from Home policy.

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