- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides ... indications.- Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… 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
- 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Operations Study Country Lead (COSCL) **Grade:** L2 **Hiring Manage:** Nicole Ferguson **Location:** Remote/Field **About the ... 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 (Warren, NJ)
- …internal and external studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation ... office locations. Fully remote is not eligible._ The **Senior Clinical Study Lead** (CSL) is expected to...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… more
- Regeneron Pharmaceuticals (Warren, NJ)
- … Concepts (CSC) * Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases ... in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets… 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
- Sanofi Group (Morristown, NJ)
- …of digital biomarkers and Digital Health Technologies (DHTs) across Sanofi's clinical studies . Working closely with global and local study teams, you will ... (including studies ) in a combination of biomedical engineering, clinical research, digital biomarker operations , clinical operations , study … more
- Sanofi Group (Morristown, NJ)
- …to the submission of publications and presentations arising from Sanofi Specialty Care sponsored clinical studies , including Phase 3 and 4 studies , and ... up-to-date knowledge of statistical methods, especially those related to human clinical studies ; including composite endpoints, time-to-event and recurrent event… more
- Sanofi Group (Morristown, NJ)
- …Generation Lead and other evidence generation-related functions for the subcutaneous formulation: Clinical Study Unit (CSU), Real World Evidence (RWE), Health ... Economics Outcomes Research (HEVA), Medical Operations and Effectiveness (MO&E) and country teams....support programs, CSRs, etc) + Oversee medical tactics and clinical study budgets planning and execution to… more
- Immigration and Customs Enforcement (Elizabeth, NJ)
- Summary The Health Services Administrator supervises healthcare operations at large ICE Health Service Corps (IHSC) facilities, ensuring compliance with policies, ... Serves as the Responsible Health Authority (RHA), overseeing the day-to-day operations of the healthcare services mission within the facility. Ensures the… more
- Sanofi Group (Morristown, NJ)
- …ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies .Ability to synthesize and critically analyze data ... Our department bridges the gap between technical development, manufacturing operations , and global regulatory authorities to ensure compliance while optimizing… more
- IQVIA (Parsippany, NJ)
- To be eligible for this position, you must reside in the same country where the job is located. The General Manager for our Contract Sales practice will be primary ... by: + Manage expenses and drive profit growth. + Working with operations to support clients effectively, including recruiting, training, project management, etc. +… more
