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Reporting to: Country Manager
Desirable qualifications and background
- Academic degree in natural science such as medicine, pharmacist biomedicine or similar
- Experience from pharmaceutical, biotechnology or medical device industries
- Experience from Clinical Research Organizations (CRO)
- A well developed understanding for customer care and business development
- 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
Principal duties
- Lead the study team and ensure that the team members perform their duties according to timelines
- Planning, co-ordinating and execution of projects
- Managing project budget
- Prepare the Clinical Study Documentation together with the study team
- Organizing study supplies
- Assist the study team during audits and inspections
- Prepare and complete applications to the regulatory authorities and ethic committees
- 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.
- Training of staff
- Planning, participating and leading Investigators meeting
- Writing and preparing the Clinical Study Documentation
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