Senior Clinical Research Associate Sweden, København Denmark, Vantaa Finland, Norway,
Posted on : 10 July 2017
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
- 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
182 17 Danderyd Sweden1310 København K DenmarkRajatorpantie 41 01640 Vantaa FinlandNO 1366 Lysaker Norway
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