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tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high
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tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems. Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high
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-author abstracts, posters, presentations and publications. May contribute budget execution of protocols. Interact with regulatory authorities, key opinion leaders, and principal investigators: May support
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abstracts, posters, presentations and publications. May contribute budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators: Supports Clinical
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responsible for supporting VRD vaccine programs, has primary scientific responsibility in the evaluation of vaccine candidates. The incumbent is expected to develop, qualify, and transfer diagnostic and
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QUALIFICATIONS Bachelor's degree in a health science required. PharmD, PhD, or equivalent terminal doctoral degree highly preferred Bachelor's degree in pharmacy with other (Doctoral or Master level) degree will
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-budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators. Leads Clinical Regulatory Authority interactions, accountable for providing responses
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enrollment and study delivery timelines. The clinical study lead will be the primary liaison for investigators who have enrollment or extraordinary protocol issues that require escalation and may need
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distilling complex analysis and concepts into concise business-focused takeaways. QUALIFICATIONS: • Bachelor's degree with 7+ years of experience OR Masters Degree with 6+ years of experience OR PhD with 2
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and graphing; reporting (Spotfire); and systems for document management and learning management. PREFERRED QUALIFICATIONS Master's degree Regulatory inspection experience Quality or compliance