Innovaderm Research Inc.
Innovaderm Research Inc.
Innovaderm Research Inc. — дерматологияға маманданған келісімшарттық зерттеу ұйымы (CRO). Компания I фазадан IV фазаға дейінгі клиникалық әзірлеу үдерістерін қолдайды. 2000 жылдан бері ол Солтүстік Америка мен Еуропадағы фармацевтикалық және денсаулық сақтау ұйымдарымен жұмыс істеп, дерматологиялық зерттеулер үшін зерттеу дизайны, реттеуші кеңес беру, жобаларды басқару, пациенттерді тарту және деректерді басқару қызметтерін ұсынады.

Clinical Data Coordinator – India (Remote)

Support clinical trial data review, reconciliation, and reporting at Indero, a dermatology and rheumatology contract research organization. Contribute to database management, study documentation, and regulatory compliance.

Сипаттама

  • Support clinical data management activities for clinical trials undertaken or managed by Indero
  • Maintain clear, accurate, and secure collection, management, and reporting of clinical trial data
  • Perform work in line with regulatory requirements, industry guidance, Indero SOPs, sponsor requirements, and timelines
  • Provide data management support to project teams, sponsors, and external vendors
  • Assist the Lead Data Manager with data review, reconciliation, discrepancy management, study metrics, and status monitoring
  • Prepare data status reports for the project team as needed
  • Produce ad hoc study reports
  • Maintain user access and records
  • Support user acceptance testing
  • Assist with clinical database design
  • Help prepare the data management plan and related documentation
  • Help keep data management documentation complete and current in the trial master file

Талаптар

  • Bachelor of Science degree or a related qualification
  • At least one year of clinical data management experience in the pharmaceutical industry or a CRO environment is considered an asset
  • Experience with an EDC system such as Medidata Rave or Medrio is considered an important asset
  • Proficiency with computer technology and the ability to learn new applications
  • General knowledge of CDASH and SDTM is considered an asset
  • Strong organization, attention to detail, project planning, and time management skills
  • Strong spoken and written English communication skills; French is an asset
  • Ability to work in a fast-paced environment while managing and prioritizing competing demands
  • Excellent interpersonal, communication, problem-solving, and organizational skills, with the ability to work independently and collaboratively
  • Understanding of drug development and applicable regulations, including Good Clinical Practice, ICH Guidelines, and relevant Health Canada and FDA regulations or guidelines
  • Legally authorized to work in India

Артықшылықтар

  • Flexible working schedule
  • Permanent full-time employment
  • Company benefits package
  • Ongoing learning and development
  • Opportunities for career advancement
  • Stimulating work environment

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