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Senior Clinical Study Manager
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Full-time
- The Senior Clinical Study Manager (Sr. CSM) will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements.
- Duties involve contributions to multiple clinical studies of differing phases, project planning, budgeting, participating in the selection of clinical sites, selection and management of clinical vendors, organizing and conducting Investigator Meetings, making clinical presentations, etc.
- Effectively collaborate with the operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs as necessary regarding performance (KPIs) related to clinical study vendor(s) ensuring compliance with study specifications (i.e., timelines, deliverables, budgets) and applicable SOPs
- Execute study management with thorough understanding of the drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA) and applies this knowledge to all aspects of the study (startup through conduct to closeout)
- Communicate with cross-functional colleagues (Regulatory, QA, CMC, Finance, etc.)
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