- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director can be an extension to the Asset Lead when needed and serve as an SME ( Subject Matter Expert ) on applicable Study Managment processes. He/she ... Director, Global Clinical Operations on plans for successful implementation of studies . Responsible to ensure the management of assigned assets at the program… more
- Merck & Co. (Rahway, NJ)
- …clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. Mentors ... operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have… more
- Merck & Co. (Rahway, NJ)
- …enable clinical development at our Company. Key responsibilities: Serve as a subject matter expert in Genomics assay development and fit-for-purpose ... development across all therapeutic areas and all phases of clinical development at our Research & Development...the use of minimal residual disease assays to support clinical studies Deep understanding of disease biology… more
- Merck & Co. (Rahway, NJ)
- …in support of clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) - ... (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Research ...proven ability to execute on collaborative projects and develop subject matter expertise-- - Knowledge of order… more
- 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
- Insmed Incorporated (NJ)
- …deliverables.Communicate and counsel Insmed senior leadership on HEOR strategic priorities.Collaborate as a subject matter expert on HEOR and a strategic ... business needs.Engage with external partners (regulators, HTAs, payers, providers, patients) as a subject matter expert on Insmed's HEOR evidence generation… 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 ... 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
