- Half-time contract till December, after that full-time.
- Manage/oversight the operational aspects of a multinational (EU) phase III pivotal clinical trial.
- Oversight of all activities delegated to vendors according to SOPs.
- Tracking of all study related activities.
- Review, tracking and distribution of essential documents and study plans.
- Tracking of study milestones.
- Tracking of recruitment.
- Pro-actively ensure recruitment figures and milestones are fulfilled.
- Management and tracking of study team training.
- Regulatory and Start Up strategy planning and tracking.
- Oversight and tracking of monitoring activities.
- QC of TMF.
- Oversight and tracking of other third party vendors (other than the CRO) activities (i.e. lab, statistics….)
- Tracking of study budget and contracts.
- Previous experience in managing pivotal phase III multinational clinical trials with several vendors.
- Ability to organize and manage priorities.
- Fluent in English.
- Excellent communication skills.