- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end ... and procedures, quality standards and adverse event reporting-requirements internally and externally.The Clinical Research Manager (CRM) could be responsible… more
- Merck & Co. (Rahway, NJ)
- …on clinical trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - career ... will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or...to local regulations, company SOPs and ICH GCP.As line manager the role is critical to continuously develop key… more
- Merck & Co. (Rahway, NJ)
- …for our organization, comprising of Process Research & Development, Analytical Research & Development, and Pharmaceutical Sciences & Clinical Supply. The ... or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding… more
- Merck & Co. (Rahway, NJ)
- …Degree in life sciences, preferred.Required experience and skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH).Ability to ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the clinical study team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with ... budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a...or More Years with PharmD/PhD preferredExperience considered relevant includes clinical or basic research in a Pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure… 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
- Novo Nordisk Inc. (Stamford, CT)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). 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)
- …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)
- …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)
- …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)
- …or related role in a biotech or pharmaceutical companyDemonstrated success as a project manager /leader in planning and executing strategies for global drug ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position is… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the… 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 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)
- …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
- 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
