- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Operations Study Country Lead (COSCL) **Location:** US Remote **About the Job:** Are you ready to shape the future of medicine? ... helping our teams accelerate progress. 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 ... The **Senior Clinical Study Lead** (CSL) is expected...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
- Parexel (Trenton, NJ)
- …and regional study management. + Contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure ... regulations (eg FDA, EMA, NMPA, etc.). As such, the Clinical Operations Manager (COM) is responsible for...team (eg Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations , other GCTO functional areas, Pharmacovigilance… 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
- Sanofi Group (Morristown, NJ)
- …with the PDS, notably the engagement strategy, mindful of Regulatory Policy, Clinical Operations and payer value implications. Verticalization of local patient ... + Responsible for establishing, aligning and integrating strategic opportunities to accelerate clinical trials with Clinical Study Units (CSU) to… more
- ICON Clinical Research (Basking Ridge, NJ)
- …you will play a vital role in managing the logistics and distribution of clinical trial supplies, ensuring that study sites receive the necessary materials in ... Doing:** + Managing the planning, procurement, and distribution of clinical trial supplies to study sites. +...with vendors and suppliers to maintain effective supply chain operations . + Providing support during audits and inspections related… 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
- Bristol Myers Squibb (Princeton, NJ)
- …analytics. This is an ideal opportunity for professionals with backgrounds in consulting, clinical operations , or trial analytics who are ready to take ownership ... of delivery and help shape the success of global studies . **Key Responsibilities** + Own study -level analytics...scoring, and performance dashboards + Engage directly with cross-functional study team members ( clinical , feasibility, ops, TA… 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