- IQVIA (Bridgewater, NJ)
- …Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.; * ... Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives by… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of regulatory intelligence processes and procedures to build efficiencies with more senior leaders + Managing more complex intelligence query requests from internal ... regular updates on new information that could impact clinical trial execution as well as ad hoc requests to...from global requirements database as well as interaction with local country experts as needed + Share/Input data into… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a ** Senior Manager , Clinical Sciences** to lead in the development, evaluation, planning and execution of clinical studies and ensures scientific ... of study data of a clinical development program. The Senior Manager reports to the Director, Clinical...relevant sections and review other scientific portions of clinical trial protocols and amendments + Assisting with and may… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related ... CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred + If you have a high...salary ranges are shown in accordance with the applicable local law and currency. If you are outside the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Development Operations & Portfolio Management (DO&PM) Vendor & Relationship Management (VRM) position is responsible to ensure that ... of best practices, documentation maintenance, and SOP compliance checks. As a Sr Manager DO&PM Vendor and Relationship Management, a typical day includes: + Provide… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Sr Manager , Clinical Drug Supply & Logistics** is responsible for providing oversight of individual or multiple clinical programs, forecasting Investigational ... sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …resourcing, quality, timelines, budget, standard processes, and training needs. Keeps senior leadership informed of decisions and issues which impact the department. ... therapeutic areas (ie, understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions. +… more