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Clinical Operations Project Lead
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- Aligns with Site Partnership Manager (SPM) on activities to engage with sites: calls & meetings for site engagement regarding site motivation and performance or other study related topics, Participate in SIVs as needed
- Establish regular exchange with GBU Medical Affairs regarding trail conduct and medico-marketing activities, e.g. publications, congress symposia
- Ensure high quality for data collection and queries resolution at the country level, (prepares/reviews site enrollment cap increase request; Reviews and follows CAPAs raised through RBM alerts and deviation/issues reporting)
- Planning Study start-up, anticipate implementation of protocol amendments, resulting in shifts in study timelines, recruitment and retention challenges, data management and vendor related issues.
- Medical Affairs colleagues form GBUs, e.g., Medical Manager, Medical Science Liaison (MSL): Field insights, site specific collaboration as indicated by CSU, KOL management.
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