- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups ... at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and… more
- Actalent (Bridgewater, NJ)
- …phases I-III. **MUST BE LOCAL TO GO ONSITE 2-3X PER WEEK** Summary: Senior Manager , Global Trial Optimization (GTO) will lead program or study ... decisions. Additional Skills & Qualifications: + 5-7+ Years of Global Trial Optimization (Feasibility) Experience (Pharma/CRO/Biotech) as a LEAD/ Manager +… more
- 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)
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups ... teams, as appropriate and as needed + Interact with senior Oncology Franchise leadership teams to ensure Quality is...proactively represented at program level and along the clinical trial process in support of a proactive quality risk… 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
