- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree… more
- Insmed Incorporated (Bridgewater, NJ)
- …and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and ... processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of...a Clinical Operations Experience considered relevant includes clinical and/or basic research in a bio/ pharmaceutical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership ... for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable... Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required; Advanced degree preferred A minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical , biotechnology, CRO ... best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical Requirements Up to 10% overnight travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations / … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program ... preferred 4 or More Years with PharmD/PhD preferred Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred. Advanced degree preferred A minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical , biotechnology, CRO ... deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites Support local/ global quality projects to improve ... monitoring experience required A minimum of 6 years of progressively responsible clinical trial experience within a pharmaceutical , biotechnology, CRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical Trial Material (CTM) and will also ... years of related experience related experience, including IT/system management in Pharmaceutical Development / Clinical research, and Project Management… more
- Novo Nordisk Inc. (Chicago, IL)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites and risks to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a ... target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead,… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and… more
