- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will ... and trending to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project manage GCO… more
- Merck & Co. (Rahway, NJ)
- …end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing ... making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global organization with...operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... clinical study team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with internal… more
- Merck & Co. (Rahway, NJ)
- …impact today.--Overview:-- -Merck Research Lab's (MRL) Pharmaceutical Sciences & Clinical Supplies (PSCS) organization is responsible for translating a therapeutic ... a functional drug product optimized for patients and for ensuring the availability of clinical supplies for patients. Within the PSCS team is the Global Clinical … 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 ... responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research 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
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety… more
- Merck & Co. (North Wales, PA)
- …Summary: This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the ... cross-functional team.Job Responsibilities: Responsible for leading specific aspects of clinical /scientific execution of clinical protocol(s). This may… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best… 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 ... and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to… more
- Merck & Co. (Rahway, NJ)
- …Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc . ) Education /Experience Bachelor's Degree +2 years of pharmaceutical, clinical drug ... This position contributes to the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to develop your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility ... if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new...Science, serving as a key contact point into the Clinical Data Science and Evidence (CDSE) Real World Evidence… more
- Merck & Co. (North Wales, PA)
- …knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.) Education /Experience:Bachelor's Degree +5 years of pharmaceutical, clinical drug ... 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)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... to support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical… more
