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Understands clinical trial operational complexities from study start up through enrollment, quality assurance, and study readout. MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process.
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Applicants who qualify on the basis of major study in biology or geology must have had at least 6 semester hours in the major directly concerned with marine science or 6 semester hours in oceanography; applicants who qualify on the basis of other physical sciences or engineering must have had differential and integral calculus and at least 6 semester hours in physics.
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Aid in staining tissue samples using immunohistochemistry (IHC) techniques, score samples, generate reports detailing scoring data and experimental results for study sponsors (customers). Immunohistochemistry, RNA Scope, histology or accessioning experience is preferred.
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ORA Ph. D. or equivalent doctoral degree in a related field of study such as: Sociology, Business Management, Business Administration, Public Administration, Social Science, Environmental Science, Geosciences, Political Science, Law Enforcement, or other fields related to the petroleum industry.
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Responsible for study, design, specification, and services related to electrical systems including power generation, power systems performance and control, cabling and wiring, lighting, motor control centers, communication systems, cathodic protection, grounding, lightning protection, heat tracing, etc.
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Work in close collaboration with the Genmab NonClinical Safety Lead/project toxicologist, other scientists, QA, and the CRO Study Director to generate GLP and non-GLP Study Plans for. In this position you will work in close collaboration with the project toxicologists and the CRO study coordinator in our department, as well as with scientists in bioanalysis, pharmacokinetics, pharmacology, translational research, pathology, CMC, QA and other departments, to set up and oversee regulatory nonclinical safety studies performed at CROs in Europe.
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When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made.
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You will also establish and/or support close collaboration with academic researchers, including clinical study investigators as well as experts in disease pathophysiology or target receptor biology, to drive precision medicine objectives with the external medical and scientific community.
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Deep knowledge in biomarker technologies including NGS, immunoassay, genomics, proteomics, and immunohistochemistry including assay validation required. 10 or more years of relevant experience in academia and/or pharmaceutical industry in translational research with strong, demonstrated expertise in immunology and/or immuno-oncology required.
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Ability to convey HEOR study results to internal cross-functional teams in a clear, non-technical manner. Create interpretable deliverables, including data tables, graphs, charts, and study reports.
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Contributes and reviews safety sections of study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling. Highly developed skills in verbal and written communication, planning, organization, with extensive knowledge of the investigational clinical study and post-marketing setting.
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This person will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology.
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The Communication Sciences & Disorders department is housed approximately two miles from campus in Bloomfield, NJ. Classrooms (6), research laboratories (6), teaching laboratories (2), a computer laboratory, student lounge and study areas, faculty and staff offices, and the Center for Audiology and Speech-Language Pathology are located in a 40,000 square foot, accessible space with ample parking.
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Serve as study director for trials: Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications.
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The Laboratory Associate IHC contributes to our mission by assisting Scientific Project Managers with sponsor contracted studies. DLS is looking for a talented and passionate Laboratory Associate-IHC to join our dynamic CARs/TissueBioMarkers team.
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study job Title: engineering manager in Newtown, PA
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