- 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
- Merck & Co. (Rahway, NJ)
- …Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the ... Operations .Collaborates internally with HQ functions, regional and local operations , EU Clinical Development, Pharmacovigilence, Global Medical Affairs to… more
- Merck & Co. (Rahway, NJ)
- …situations of low or non-performance.The role will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical ... Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role...the CTCs, as well as for interns-delegated to the Clinical Operations team based on the Internship… 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)
- …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)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our… more
- Merck & Co. (North Wales, PA)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of ... continuity of site relationships through all-phases of the trial.Performs clinical study site management/monitoring activities in compliance with ICH-GCP,-Sponsor… more
- Novo Nordisk Inc. (Los Angeles, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Merck & Co. (Rahway, NJ)
- …for a wide range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial ... improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide… 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 ... difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ownership to position & deliver upon near ... clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical ...compliance with standard processes, policies and procedures Collaborates with Clinical Finance & Operations to ensure the… more
- Aequor (NJ)
- …and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners. Collaborating with Global Clinical ... 100 % remote Manager prefers local candidates (will consider non local...CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure… 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)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of… more
- Novo Nordisk Inc. (Cincinnati, OH)
- …personal development. Are you ready to realize your potential? The Position The Manager - Pharmacy Execution will work with Regional Business Directors (RBDs) and ... Pharmacy Strategy that aligns to Brand Strategies and National Account Strategies. The Manager - Pharmacy Execution will achieve this goal by driving and managing… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… 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
