- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years relevant experience is required with a BSc requiredExperience in clinical operations methods and processes in industry setting requiredExperience ... and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction...considered relevant includes clinical or basic research in a pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature… 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 ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… 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 ... 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)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of ... and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to...More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical… 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)
- …procedures, quality standards and adverse event reporting-requirements internally and externally.The CRM ( Clinical Research Manager ) could be responsible for ... Reports and escalates performance issues and training-needs to CRA ( Clinical Research Associate) manager and/or...the CTC Clinical Trial Coordinator, CRAs and-COM Clinical Operations Manager ).-Responsible for creating… 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 supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Merck & Co. (Rahway, NJ)
- …for our organization, comprising of Process Research & Development, Analytical Research & Development, and Pharmaceutical Sciences & Clinical Supply. The ... their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our...the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... trial processes including experience in one or more key functions (eg, clinical research , clinical operations , data management, biostatistics, project… 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 is ... the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global… 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 ... strategies for cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify data anomalies, inconsistencies,… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory ... 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… 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, ... security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the… more
- Hackensack Meridian Health (Hackensack, NJ)
- …our mission to transform healthcare and serve as a leader of positive change. The Manager , Clinical Research Ops is responsible for the Clinical ... clinical support staff for all areas of Clinical Research across the HMH network, ensuring...management for Phase I, II, III and IV study operations for the network research activity and… more
- Merck (Rahway, NJ)
- …quality standards and adverse event reporting requirements internally and externally. The CRM ( Clinical Research Manager ) could be responsible for a ... and escalates performance issues and training needs to CRA ( Clinical Research Associate) manager and/or...CTC Clinical Trial Coordinator, CRAs and COM Clinical Operations Manager ). + Responsible… more
- Weill Cornell Medical College (New York, NY)
- Title: Clinical Research Project Manager Location: Upper East Side Org Unit: Cardiac Research Work Days: Monday-Friday Exemption Status: Exempt Salary ... role when Hired for NYC Offices **Position Summary** The Clinical Research Project Manager supervises...key role will serve as the expert in project operations including study design, study conduct, data management, and… more
