Everest Clinical Research
Everest Clinical Research
Everest Clinical Research एक वैश्विक कॉन्ट्रैक्ट रिसर्च ऑर्गनाइज़ेशन है, जो दवा और जैव प्रौद्योगिकी प्रायोजकों को क्लिनिकल ट्रायल से जुड़ी एंड-टू-एंड सहायता प्रदान करता है। इसके कार्य में क्लिनिकल संचालन और परियोजना प्रबंधन, जोखिम-आधारित गुणवत्ता प्रबंधन, केंद्रीकृत निगरानी, चिकित्सा निगरानी, फार्माकोविजिलेंस, क्लिनिकल डेटा प्रबंधन, बायोस्टैटिस्टिक्स, सांख्यिकीय प्रोग्रामिंग, नियामक रणनीति और सबमिशन शामिल हैं। कंपनी IRT/RTSM और ePRO/eCOA जैसी क्लिनिकल प्रौद्योगिकी समाधान भी प्रदान करती है तथा ऑन्कोलॉजी, न्यूरोलॉजी, श्वसन रोगों, दुर्लभ रोगों और इम्यूनोलॉजी में चिकित्सीय विशेषज्ञता रखती है।

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.

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

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

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