- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, ... with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a...to process standards and tools to achieve excellence in trial operations and management.Monitor and ensure compliance… more
- Merck & Co. (North Wales, PA)
- …to patient enrollment and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites ... policiesMaintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI)Research: Upon… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... department (subset) of NACD and/or as part of a global team and as aligned to a business case,... clinical trials, document management and management of clinical trial management systems and archiving systems.… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the ... project plans, ICH/GCP guidelines, government regulations, etc.Provides operational support for the Clinical Operations team with heavy focus on study start‐up… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has ... for all therapeutic areas. The role reports into the Global Clinical Operations VP and...Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered… more
- Novo Nordisk Inc. (Atlanta, GA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... department, (subset of) NACD and/or as part of a global team and as aligned to a business case,...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic outsourcing and performance indicators In collaboration with other Vice Presidents of Clinical Operations in other global locations and therapy ... Clinical Operations line management experience Domestic and international clinical trial execution experience required Post-approval clinical … more
- Merck & Co. (Rahway, NJ)
- …the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. ... to:Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited to: data management...with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource allocation.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Business Strategy (FBS), Strategic Operations (SO, Human Resources. Key global stakeholders include: various stakeholders within Clinical Drug Development ... best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical Requirements Up to 10% overnight travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations… more
- Merck & Co. (North Wales, PA)
- …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... Affairs, Medical Strategy & Operations , Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written...your employment may pose an undue burden to business operations , in which case you may not be offered… 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 ... checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates… more
- Merck & Co. (North Wales, PA)
- …portfolio.Execute and manage existing pathology strategies for early and late-stage clinical trial support.Exercise foresight and judgment in planning, ... trials for evaluation of efficacy and safetySkill in authoring clinical pathology operations documents for trials using...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who ... This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply...trials Deep understanding of Distributor, Logistics and Demand Planning Operations , Global Supply Chain, Cost Reduction and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs.Help to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations / Clinical Quality Management or ... and proactively represented at program level and along the clinical trial process in support of a...new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections,… more
- Merck & Co. (North Wales, PA)
- …of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied ... of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required Experience and Skills: Experience leading large… more
