31 ago - Reggio Calabria
Precision Medicine Group
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
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As our company continues to grow we are seeking a Site Start Up Lead APAC to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan/China.
Position Summary: The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval,
IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.
Essential functions of the job include but are not limited to:
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- Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
- Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
- Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely deliv
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