- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited to: data management...and implement changes as appropriate at the trial level, program level, TA level and department Level.Performs tasks with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the US. Within the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, ... NJ campuses through both direct leadership of the core Clinical Operations function, as well as ensuring...and future development of the area Oversee and trouble-shoot clinical development program challenges, processes, activities and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams ... 1-3 clinical trials at the study and program level. Responsible for clinical program...StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies ... veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of… more
- Merck & Co. (Rahway, NJ)
- …of the FLEx complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process ... based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research and Development Division (R&D).-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data ... air and surface sampling, related to Raritan manufacturing processes, either for clinical trials and commercial operations in a controlled cGMP cleanroom… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …global regulatory operations , biostatics, data management, clinical science and clinical operations . The Network Lead will have direct accountability ... patient on study, other KPIs and KQIs.Works with OEDC Program Lead to design and update of...assessing potential new FIH sites and in FIH site clinical operations methods required.Experience in site selection… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Training Supervisor - Operations as part of the Training team based in Raritan, NJ. Role Overview The ... will be responsible for supervising the training team who lead training activities for the overall plant team members...for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the effective use of tools such as kata methodology, A3 thinking, 4Ups, 6S. Lead and teach others within Operations to participate in kaizen events. Facilitate, ... the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the Technical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal functional areas including, Managed Markets Sales, Managed Markets Strategy & Operations , Medical, CE, LGQ, , Trade, Institutions and Market Shaping, as ... initiatives including but not limited to KOL development, advisory boards, clinical communications and medical education programs Responsible for the development of… more
- Merck & Co. (Rahway, NJ)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... for the benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides… more
- Merck & Co. (North Wales, PA)
- …insight, knowledge of the therapeutic area, and scientific expertise, they will lead the development of comprehensive publication strategy and plans as well as ... current publication policies and industry trends.Responsibilities:With oversight from the Director Lead , lead development of and maintain publication strategy… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine ... program .- Develops and manages project plans which span from...more senior staff, may serve as the data management lead or perform a support role for filing programs.… more
- Merck & Co. (Rahway, NJ)
- …upper management and other disciplines to drive enterprise decisions.May serve as a program lead on programs that carry significant technical and/or operational ... process development, and/or engineering and regulatory science.Proven ability to lead program development teams using project management skills.Preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role Overview Technical Trainer will be responsible for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell ... Key Responsibilities Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …new technologies. Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, ... to ensure Quality is consistently and proactively represented at program level and along the clinical trial... programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations … more
- Merck & Co. (Rahway, NJ)
- …patients and global human health. Responsibilities :Serves as a statistical lead in project teams.Develops, coordinates, and provides biostatistical leadership and ... for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and other company… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes… more
