Reporting to: Office Manager/Clinical Research Manager

Desirable qualifications and background
• Academic degree in natural science such as life sciences
• Experience from pharmaceutical, biotechnology or medical device industries
• Experience from Clinical Research Organizations (CRO)
• Good ability to express yourself both verbally and in writing
• Good knowledge of spoken and written English
• Good organizational skills
• A service-minded approach
• Ability to prioritize and handle several tasks simultaneously
• Valid driving license

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 etc.
• Responsible for the sites and on-site management during the study process
• Drug accountability
• Participate in Audits and Inspections
• 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

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