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Innovaderm Research Inc.
Innovaderm Research Inc.
201 – 500 Angajați
Asistență medicalăConsultanțăProduse farmaceutice
Innovaderm Research Inc. este o organizație de cercetare contractuală (CRO) axată pe dermatologie, care sprijină dezvoltarea clinică din faza I până în faza IV. Din 2000, compania colaborează cu organizații farmaceutice și din domeniul sănătății din America de Nord și Europa, oferind servicii de proiectare a studiilor, consultanță de reglementare, management de proiect, recrutarea pacienților și gestionarea datelor pentru cercetarea dermatologică.
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Locurile de muncă ale companiei

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.

INIndiaRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCoordonator de date cliniceGeneral

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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