- Organon & Co. (Jersey City, NJ)
- …through development and to meet project timelines. + Serving as the subject matter expert in the non- clinical field in meetings with internal/external ... Serve as a subject matter expert and/or provide technical area expertise for non- clinical... Operations, coordinate non- clinical pharmacology and toxicology studies at Contract Research Organizations (CROs). +… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …high level of knowledge of study-specific documents. **Job Duties** + Act as the Subject Matter Expert and primary point of accountability and reconciliation ... develop, implement, and coordinate study procedures to successfully manage clinical studies . The Sr. CTC will perform...resolution of data queries under the guidance of the Clinical Research Associate (CRA), Data Management and/or… more
- CSL Behring (Waltham, MA)
- …and define next steps across areas of expertise for often complex issues. Recognized subject matter expert in job area typically obtained through advanced ... in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies . This role will support the external tactical execution of… more
- CSL Behring (Waltham, MA)
- …turn around times, assay transfers, budgets, and resource allocation.? Scientific Oversight? Recognized subject matter expert in job area typically obtained ... report to the Senior Director, Global Lead and Head Research and Clinical Bioanalytics. You will lead...of bioanalytical and biomarker assays to support nonclinical and clinical studies . This role requires a strategic… more
- Terumo Medical Corporation (Somerset, NJ)
- …mitigation strategies, and serving as a subject matter expert for inspection readiness. The Sr. Clinical Quality Specialist collaborates ... execution of Clinical Risk Management Plans and Clinical Quality Plans for studies Conducting audits...clinical vendors required. - Certification in auditing or clinical research (eg, CQA, RQAP-GCP, CCRA) required.… more
- CSL Behring (Waltham, MA)
- …and define next steps across areas of expertise for often complex issues. Recognized subject matter expert in job area typically obtained through advanced ... of bioanalytical and biomarker assays to support nonclinical and clinical studies . This role will lead the...and excellence. Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality,… more
- CSL Behring (Waltham, MA)
- …and define next steps across areas of expertise for often complex issues. Recognized subject matter expert in job area typically obtained through advanced ... vaccine serology and biomarker assays to support nonclinical and clinical studies . This role will lead the...and excellence. Participate in external due diligence and provide expert advice on vaccine serology and biomarker assays ,… more
- Organon & Co. (Jersey City, NJ)
- …to market opportunities. + Represent the Clinical Pharmacology function or serve as subject matter expert for translational medicine and clinical ... briefing books, IND subsections, submission modules and other regulatory documents. + Provide clinical pharmacology subject matter expertise and lead the… more
- Stanford Health Care (Palo Alto, CA)
- …follow-up. + Supports regulatory audits and other compliance requirements. + Acts as the subject matter expert for all pharmacy billing programs. + Responds ... operations team members to assist with other duties as needed. + Research activities (eg abstracts, posters, publications) are encouraged. + Attends Pharmacy… more
- BeOne Medicines (San Carlos, CA)
- … sample analysis to generate high-quality and robust biomarker data. + Serve as subject - matter expert ( SME ) in mass spectrometry technologies (triple ... and qualitative mass spectrometry assays to support pharmacodynamics study and biomarker research in clinical trials as well as proteomics exploration. The… more
