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EDETEK Inc.
EDETEK Inc.
201 – 500 Қызметкерлер
SaaSБиотехнологияФармацевтикалық өнімдер
EDETEK Inc. develops clinical informatics software and services for pharmaceutical, biotechnology, and medical device organizations. Its cloud-native R&D ecosystem brings together an eClinical platform for managing clinical trials and preparing regulatory submissions, including tools for study orchestration, CTMS, EDC, ePRO/eCOA, RTSM, data integration, metadata management, and statistical computing. The company also provides biostatistics and programming, clinical data management, study development, medical writing, and eClinical operations. EDETEK focuses on connecting clinical data and supporting its quality across the study lifecycle, with AI-enabled capabilities as part of its platform.
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Компаниядағы жұмыс орындары

Remote Clinical Data Management Manager

Lead clinical data management delivery for EDETEK’s CONFORM eClinical implementations and clinical trial projects. Oversee client coordination, user acceptance testing, documentation, and development of junior team members.

USАмерика Құрама ШтаттарыҚашықтанТолық жұмыс күніКіші маманОрта деңгейҚажетті Тіл: ағылшын тіліКлиникалық зерттеулер

Сипаттама

  • Lead the clinical data management team.
  • Maintain project management documentation.
  • Deliver clinical data management work and implement EDETEK’s CONFORM eClinical system.
  • Develop design specifications for system forms, reports, and related components.
  • Coordinate testing for system implementations.
  • Manage data management projects to meet quality standards and deadlines while maintaining client satisfaction.
  • Assess client needs and develop project solutions using relevant expertise, operational resources, and technology.
  • Communicate with clients and internal teams.
  • Contribute to internal clinical data management initiatives.
  • Carry out routine and assigned data management operations.
  • Discuss client requirements and issues, uphold standard operating procedures, and track project progress and timelines.
  • Help develop and maintain systems that support project infrastructure.
  • Work with Clinical Data Specialists to carry out Data Management Plans.
  • Coordinate with clients and sponsors to deliver contracted clinical data management services with quality and integrity.
  • Ensure required documents are filed according to EDETEK and project requirements.
  • Lead user acceptance testing for new software.
  • Select and interview clinical data manager candidates.
  • Train and mentor junior team members.

Талаптар

  • Communicate effectively in English in person, by phone, and in writing.
  • Lead functional meetings.
  • Maintain strong attention to detail and accuracy.
  • Demonstrate excellent organizational skills.
  • Manage multiple projects effectively.
  • Work collaboratively and productively across diverse organizational structures.
  • Work independently, take initiative, and meet deadlines while demonstrating excellence, customer service, accountability, ownership, and cross-functional communication.
  • Contribute effectively in a team-oriented, collaborative environment.
  • Adapt positively to ongoing change.
  • Prioritize and complete work effectively in a high-pressure environment.
  • Use computers proficiently, including Microsoft Office and potentially project management software.
  • Hold a bachelor’s degree or an equivalent combination of education, training, and experience; a scientific, medical, or technology degree is preferred.
  • Have at least two years of clinical trial, clinical data management, or comparable industry experience or training.
  • Prior responsibility for the full trial data management lifecycle is desirable.
  • Have working knowledge of EDC studies and SAS.
  • Work in a corporate office environment.
  • Be available for occasional travel, up to 5%, potentially including weekends.
  • Collaborate across functions.

Артықшылықтар

  • Choice of comprehensive medical, vision, and dental insurance plans.
  • Paid vacation and sick leave.
  • Annual corporate holidays.
  • Participation in the 401(k) plan.
  • Perks and discounts covering AAA, wholesale, insurance, prescriptions, fitness, pets, entertainment, and more.
  • Health Advocate and Employee Assistance Program.

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