- Merck & Co. (Rahway, NJ)
- …procedures, quality standards and adverse event reporting-requirements internally and externally.The CRM ( Clinical Research Manager ) could be responsible for ... Monitoring Visits Reports and escalates performance issues and training-needs to CRA ( Clinical Research Associate) manager and/or functional vendor and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Efficiency / Continuous Improvement:Provides comprehensive data management expertise to project /study teams to optimize study-specific clinical trial ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position manages… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination. This position collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the ... for planning, managing, and coordinating projects within DSI CSPV and global clinical safety and epidemiology function. Deliver the project according to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance...More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project . ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....more complex projects in collaboration with a more senior project manager . Establishes and maintains a high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Manager ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of ... and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or more key functions (eg, clinical research , clinical operations, data management, biostatistics, project management) required- Collaboration, ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of Novo ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...Director - Accelerated Efficiencies and Optimization, Strategic Operations. The Project Manager regularly works with members of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position will ... organization and will work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory ... Data Manager will be a key member of the Global...well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Insmed Incorporated (Bridgewater, NJ)
- …our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development, business analyses or consulting experience. required andPrior work experience as a project manager , project lead, or similar role within ... Clinical Development (GOCD) Functional Excellence supports process improvement project activities by ensuring efficient and effective execution. This role works… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products Create and maintain product/ project database to ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
