- Aequor (Basking Ridge, NJ)
- …drug supply forecast for packaging and labeling operations . Support patient study needs that consider enrollment rates, country logistics for shipping and ... Duties: Participate in study team meeting, align with study ...drug supply as well as experience managing third-party contract clinical supply operations required Global experience required… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Operation Study Country Lead **Location** : US/Remote **About the Job** Join the engine of Sanofi's mission - where deep ... impossible into possible for millions. We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support US clinical… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Director, Medical Study Operations , will oversee several of our External Sponsored Research (ESR) programs including Investigator-Initiated Studies (IIS) ... and financial management support. **As a Director in Medical Study Operations , a typical day may include...+ Support of Early Phases molecules, post-IND filing, ensure non- clinical and non-drug studies are reviewed in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …expertise in the understanding of clinical and non- clinical study protocols and associated documentation. Manages biospecimen operations for assigned ... day may include:** + Responsible for the interpretation of clinical /non- clinical study protocols and associated...inputs. + Manages biosample operations for assigned clinical /non- clinical studies to ensure company… more
- Organon & Co. (Jersey City, NJ)
- …TMED studies . **Responsibilities** + Manage and support the operational aspects of clinical studies from study start-up through close-out. + Manage and ... TMED Operations Lead to plan and execute studies including, but not limited to, managing study... site personnel and investigators. Competencies + Phase 1 study operations + ICH/GCP + Clinical… more
- NYU Rory Meyers College of Nursing (New York, NY)
- …& Science is seeking an experienced Department Manager to join the Environmental Studies team. Reporting to the Chair, the Department Manager leads the management of ... overall departmental operations , processes, and strategic planning. Serve as a main...and excludes any additional items such as incentives, bonuses, clinical compensation, or other items.NYU aims to be among… more
- Organon & Co. (Jersey City, NJ)
- …to 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical ... design, execution (in collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies in accordance with… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a ... provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Mount Sinai Health System (New York, NY)
- …and organize study information, and assist with other day-to-day operations as required. Under minimal supervision, the Clinical Research Coordinator ... **Job Description** Under minimal supervision, coordinates the clinical assessments of the study subjects;... trials:** * Assists in the activities related to clinical research studies including but not limited… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Works in a matrix environment ... provide scientific expertise necessary to design and deliver on clinical studies and programs. As an Associate...such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …plans and clinical study reports. + Work closely with Clinical Imaging Operations and imaging contract research organizations to ensure the flawless ... studies ' imaging components and endpoints. + Serve as Study Scientific Director for clinical trials focused...unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which… more
- Mount Sinai Health System (New York, NY)
- …and organize study information, and assist with other day-to-day operations as required. Under minimal supervision, the Clinical Research Coordinator ... field. + At least 2 years' experience as a Clinical Research Coordinator, Study Coordinator, Data Manager,... trials: + Assists in the activities related to clinical research studies including but not limited… more
- Mount Sinai Health System (New York, NY)
- …team. + Coordinate with clinical and administrative staff to ensure smooth study operations . + Provide regular updates to the principal investigators and ... The Clinical Research Coordinator assists in the daily activities of clinical research studies , obtains informed consent; collects, maintains and organizes … more
- Mount Sinai Health System (New York, NY)
- …management, and coordination of care for subjects enrolled onto IRB approved research studies / clinical trials, as specified by the research protocol, across the ... group of patients/family/community members who have agreed to participate in research studies / clinical trials.Provides care to patients with acute and complex… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …preferably in solid tumor Oncology drug development. The Medical Director drafts designs of clinical study concepts which lead to clinical trial protocols ... and is responsible for medical/scientific supervision of individual clinical trials. This role may work on studies...+ Collaborates with Clinical Project Managers and Clinical Trial Managers at the study level… more
- Mount Sinai Health System (New York, NY)
- … clinical trial projects and protocols, including federally funded studies , investigator-initiated studies , and/or those from pharmaceutical companies. The ... + Strong management and leadership skills **Responsibilities** + Manages and coordinates clinical trial and related research studies conducted by the principal… more
- Organon & Co. (Jersey City, NJ)
- …+ In conjunction with Non- Clinical Operations , coordinate non- clinical pharmacology and toxicology studies at Contract Research Organizations (CROs). ... study protocols and research reports. + Authorship of non- clinical sections of IND, CTA, NDA, MAA, and relevant...documents of assets in Organon portfolio. + Ensure that non- clinical studies are conducted in compliance with… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron driven studies , and may serve as a resource to anticipate and/or resolve study clinical and conduct issues. This role reports into the Clinical ... have proficient knowledge of the drug development process, good clinical practice, study design and research methodology...unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which… more
- Mount Sinai Health System (New York, NY)
- …and documents related to operations of the function. + Oversees the clinical assessments of the study subjects including but not limited to screening, ... less experienced clinical research staff. Oversees the clinical assessments of the study subjects. Assists...Medicine **Responsibilities** + Analyzes highly complex data gathered on clinical research studies . + Interprets complex … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support ... to key external presentations. + Ensures quality of all clinical documents (eg, Investigators' Brochure, protocol, study ...unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which… more
