- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …according to the timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, ... team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry setting required.Experience ... 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)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... 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
- 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), ... including experience in one or more key functions (eg, clinical research, clinical operations , data management, biostatistics, project management) required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations , responsible for representing the GCO-CQM inspection ... to regulatory guidelines, and quality management principles. requiredExpert knowledge in Clinical Operations Phase 1 to 4 Trial Execution. requiredOncology… 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 ... 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 ... 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 ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities.… more
- Merck & Co. (Rahway, NJ)
- …for the execution of the Merck clinical research portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management ... making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global...and operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project… more
- Merck & Co. (Rahway, NJ)
- …the intellectually curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization with over ... May interact with internal and external stakeholders (eg, country operations , committees, vendors) in support of clinical ...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Merck & Co. (Rahway, NJ)
- …the intellectually curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization with over ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...of Lead Clinical Scientist and Lead Study Manager . Your Fellowship ProjectYou will partner with CSSM team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... strategies for cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify data anomalies, inconsistencies,… 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 ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, ... the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and...biotechnology experience in one or more key functions (eg clinical operations , clinical research, … more
- Merck & Co. (Rahway, NJ)
- …business processes as well as alignment with Finance, IT, and functional area operations groups within Merck. -Your Fellowship ProjectWe are seeking an energetic and ... and tactical input from diverse disciplines (eg, biology, chemistry, pharmacology, clinical , regulatory, access, supply, and other areas), as applicable to the… more
- Merck & Co. (Rahway, NJ)
- …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 ... project management, communication, and collaboration skills in-support of our clinical trials. Job Responsibilities: - Responsible for the operational planning,… 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 ... characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch records, forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, ... treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor / Sr. Operations Supervisor (2nd...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
