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In-depth knowledge of statistical methodologies, clinical trial design, and real-world evidence generation, with a focus on optimizing study design and data analysis. This key leadership position involves providing guidance and expertise in statistical methodologies, study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products.
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Programs of study leading to the degrees Master of Arts, Educational Specialist, Doctor of Education and Doctor of Philosophy are individualized to meet student needs. Uniting scholars and students from four dynamic departments—Communication, Media, and the Arts; Education Leadership, Management, and Policy; Educational Studies; and Professional Psychology and Family Therapy—the College is the new home of cutting-edge, transdisciplinary inquiry into the stickiest problems of our time.
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Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results.
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The University is also a higher education innovator within the State of New Jersey, partnering with Ocean County College, in Toms River, New Jersey and Brookdale Community College, in Lincroft, New Jersey, to provide access for students to earn a bachelor’s degree from Kean. The Kean Skylands campus, located in Jefferson Township, New Jersey, is designed to serve as an outdoor living laboratory for field-based scientific study and other classroom and field instruction.
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Staff Engineer I. POSITION OBJECTIVE This position exists to provide assistance and recommendation on corrosion related evaluation through participating of P&ID review, equipment specification review, damage mechanism review of equipment inspections, Equipment Abnormal Analysis review, PSM operations issues review, RBMI corrosion research, incident investigations, project review / study, PHA study, inspection and maintenance audit.
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Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP.
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B.S. in Mechanical Engineering, Aerospace Engineering, or equivalent field of study. Familiarity with LS-Dyna analysis package, 3D CAD programs (Creo preferred), and GD&T. Perform Finite Element (ANSYS) structural, modal, thermal, vibration and shock, line loads, fatigue detailed analysis for complex mechanisms.
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Coordinate, lead and perform clinical data management activities for assigned studies in accordance with Regeneron’s SOPs and policies and practices including, not limited to:+ Monitoring data clean-up process performed by CROs from study start-up through data archiving.
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10 years preferred with a bachelor's degree, 5 years preferred for a PhD or MS in a field of science (chemistry, biochemistry, toxicology, or relevant fields). Knowledge of analytical, non-vertebrate and vertebrate testing, as it relates to regulatory toxicology in GLP or fit-for-use conditions.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, company Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CROs, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Qualifications - Education Minimum of a Master’s Degree in NursingEarned Doctorate in Nursing PreferredNew Jersey Licensure as a Registered Professional Nurse Qualifications - Experience Minimum 5 years teaching experience in Associate or Baccalaureate Nursing Degree ProgramAdministrative experience in academic settingParticipation and service in professional and/or community organizationsWorking knowledge of all courses and programs of study offered by the department.
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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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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Clients Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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EXAMPLE RESPONSIBILITIES: Represents Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents to senior leadership as required.
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toxicology study jobs in Florham Park, NJ
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