| |
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
|
|
|
