Project Manager – Japan-based for a global labeling optimization project and a labeling text & artwork verification tool project Plan and manage the 2 projects noted above Help update the business cases to get them approved Experience managing vendor selections and implementations a plus Agile and regulatory labeling experience preferred. Business Analyst – Japan-based for […]
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CNS small molecule sponsor just launched phase 3, looking at commercialization strategy, product launch, etc. Senior Program Management role is soon to be empty. Current thinking is that it may take a while to find the right permanent replacement, looking at experienced executive consultant for the gap period. Must have small molecule NDA experience. Company […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities Primary responsibility includes oversight of clinical study execution, including project planning, resource management, CRA and CRO management, and ensuring all operational aspects of clinical trials […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]
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Small CA based biotech in need of an independent expert who knows both Veeva (any vault) AND regops. “What we’re finding is that people either know one or the other. We need both!” Number of hours and duration, not sure, it really depends on the expertise of the consultant. Deep understanding of the regops process, […]
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Services Summary: The Clinical Data and Systems Manager Lead will execute and provide input on all aspects of clinical data and systems management, including CRO interface and oversight. The focus of this role will be to provide Clinical Data Management and Clinical Data Systems Management that includes management oversight of CDM deliverables from CROs and […]
READ MOREUK based global full service CRO in need of a strong case processing project manager to lead the post marketing case processing team for 4 key clients. Must be an expert on case processing at least 5 years direct experience in post marketing case processing, and familiar/conversant with other PV concepts. Strong leadership and demonstrated […]
READ MORELarge, UK based CRO in need of a contract PM to facilitate a migration of data from one PV system onto the Oracle Cloud. Strong project management required, pharmacovigilance domain expertise also required, familiarity with Oracle Argus, both in-house as well as cloud. Project expects 20 hours a week for 6 months. Must be able […]
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