- University of Rochester (Rochester, NY)
- … clarifications (ie data queries) for each study. **ESSENTIAL FUNCTIONS** + Inspects clinical data and research data from electronic records and other ... determined by considering factors including, but not limited to, market data , education, experience, qualifications, expertise of the individual, and internal equity… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality Management Systems ... and Regulatory Affairs is responsible for establishing and promoting quality...responsible for establishing and promoting quality outcome standards towards safety , effectiveness and efficiency enterprise-wide. Provides leadership for advancing,… more
- Pfizer (New York, NY)
- …EMA, and global regulations + Extensive understanding of related disciplines, eg, Clinical Operations, Safety , Biostatistics, Regulatory , Study Management, ... and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other...Health Authority meetings, participates as appropriate. + Set the clinical data review strategy and leads the… more
- Pfizer (New York, NY)
- …and interpretation of clinical trials data together with the GDL, Clinical Safety , and Biostatistics. + Serve as technical resource for clinical ... all FIH programs through proof-of concept + Set the clinical data review strategy, ensure quality ...working with and solid understanding of related disciplines, eg, Clinical Operations, Safety , Biostatistics, Regulatory ,… more
- Mount Sinai Health System (New York, NY)
- …Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements (eg, FDA, IRB, ICH). + Oversee the preparation and ... submission of regulatory documents, including protocols, amendments, and safety ...in key areas such as protocol review, patient interactions, regulatory documentation, and data management. + Ensure… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …of all clinical documents (eg, Investigators' Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents). ... working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions....Ensures safety of the drug, including the safety aspects of patients in clinical studies… more
- University of Rochester (Rochester, NY)
- …mental health research preferred + Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards preferred ... determined by considering factors including, but not limited to, market data , education, experience, qualifications, expertise of the individual, and internal equity… more
- Mount Sinai Health System (New York, NY)
- …than three years preferred). + Experience with Just Culture and Culture of Safety principles preferred. + Knowledge of clinical quality, patient safety ... **Job Description** The Clinical Risk Manager reports to the Director of...reports to the Director of Risk Management and Patient Safety and is responsible for reviewing, summarizing, analyzing, presenting… more
- ICON Clinical Research (Farmingdale, NY)
- …of the laboratory operations. This role ensures compliance with all regulatory and accreditation requirements, guides clinical decision-making, and ensures ... and diagnoses are accurate and medically appropriate. + Oversee the laboratory's clinical activities to ensure patient safety and proper diagnostic procedures.… more
- Sumitomo Pharma (Albany, NY)
- …and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output + Contributes to interpretation of clinical trial ... as required, and working with the safety group to ensure adequacy of safety monitoring and reporting + Provide clinical input for and participate in study… more
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