- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight (CTOR&O), will collaborate with ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... needs are met through alignment of business plans and operational need within the Therapy Area and in partnership...is preferred A minimum of 12 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study...the study and propose mitigation plans.Monitor study budget against trial progress and bring deviations to the Operational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …evidence, economic models, and Global Value Dossiers- Propose and implement analysis of clinical trial data for cost effectiveness models and market specific ... of key drug development processes, plans, studies, and strategies including clinical , regulatory, scientific, operational , and commercial aspects of drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Times, Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog ... in life sciences, pharma with Clinical Trials Operational Data, Clinical Operational Metrics...KPIs, KRIs and KQIs related to large scale global clinical trial end to end execution. preferredDemonstrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Data Management and medical coding expertise to promote best practices across the Clinical Trial lifecycle.Applies GCP principles to ensure all medical coding ... end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs and other vendors to ensure high quality… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).Oversee and manage all operational aspects of phase I-IV ... Director , Clinical Operations/CPMSun Pharma Advanced Research...QualificationBachelor of Science in a life sciences discipline, or higher qualification Experience10+ years of Clinical trial … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as ... Associate Director , Clinical Operations Sun Pharma Advanced...bid-defense process under guidance and supervisionEducation and QualificationBachelor degree in life sciencesExperience7-10 years of Clinical trial … more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, ... Outsourcing Team in Princeton, NJ. The Sr. Manager, Clinical Outsourcing will report into Sr. Director ,...activities with vendors.Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as ... Associate Director , Clinical Operations Sun Pharma Advanced...and supervision Education and Qualification Bachelor degree in life sciences Experience 7-10 years of Clinical trial … more
- Taiho Oncology (Princeton, NJ)
- …of timelines, budget, recruitment and country/site selection strategies, and provision of clinical trial materials. + Serves as main study contact for ... Associate Director , Clinical Operations Pleasanton, CA, USA...sites. + Responsible for the financial management of the clinical trial in conjunction with his/her supervisor… more
- Merck (West Point, PA)
- …and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team ... design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study...are completed in accordance with applicable standards. Develops study operational documents with input from team members (eg site… more
- Bristol Myers Squibb (Princeton, NJ)
- …Global Data Management (GDM) **Functional Area Description** GDM is responsible for clinical trial data acquisition, data management and review, and medical ... **Key Competency Requirements** + Expert understanding of the drug development process and clinical trial execution. + Expert knowledge of industry trends and… more
- J&J Family of Companies (Titusville, NJ)
- …input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership ... the development and execution of medical strategies and the clinical and operational implementation of a complex...+ Responsible for the development and execution of the clinical trial protocol(s); ensures implementation of study… more
- Bristol Myers Squibb (Princeton, NJ)
- …stakeholders to support the synthesis of local trends which would influence successful clinical trial execution. + Member of the Regional Delivery Lead ... to late stage, including lifecycle management. + Deep knowledge of clinical trial operations including monitoring methodologies, systems, regulations/compliance,… more
- Merck (Trenton, NJ)
- …and retention efforts to achieve study milestones. + Upon Request from Global Clinical Trial Operations (GCTO) + Recommends study sites and identifies potential ... (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/ operational responsibilities.… more
- Bristol Myers Squibb (Princeton, NJ)
- …towards industry experience + Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical ... operational strategy/improvements. **Analysis TA Standards:** Key authority on clinical analysis standards both within BMS and externally, and collaborates with… more
