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Desirable qualifications and background

  • Academic degree in natural science such as life sciences, pharmacy or nursing.
  • At least 4 years of clinical research experience in the Pharmaceutical/CRO industry (including site initiation, monitoring and site closure).
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English and local language
  • Good organizational skills
  • A service-minded approach
  • Ability to prioritize and handle several tasks simultaneously
  • Valid driving license
  • Position requires occasional travel both national and internationally

Principal duties

  • Prepare and complete applications to the regulatory authorities and ethic committees
  • Responsible for completion of study documentation such as CRFs, patient diaries, QoL forms etc.
  • Preparing Monitoring Manuals, Source Data Verification plans, Clinical Management Plan etc.
  • Responsible for the sites and on-site management during the study process
  • Drug accountability
  • Participate in Audits and Inspections, Co-monitoring and Accompanied site visits.
  • Select and negotiate contracts with 3rd party providers.
  • Assist in data validation and clean file procedures
  • Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits
  • Selecting and negotiating contracts with local/central laboratories, pharmacies etc.
  • Planning and participating at Investigators meeting
  • Responsible for final archiving of study documents in-house and on-site