- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Head of Clinical Trial (CT) Diversity sits within Global Oncology Clinical ... that study teams will utilize to develop study specific clinical trial diversity plans Leads the strategy...of industry trends and changes in regulations related to clinical research diversity and inclusion - Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lessons learned, and enterprise-wide best practices.Reinforce DS commitment to inclusive clinical research by conducting presentations and trainings, where ... into consideration the epidemiology of the disease -Review applicable study specific clinical trial materials to ensure cultural sensitivity and health literacy… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director, Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this role is ... independently direct the execution and coordination of major change projects across Global Clinical Trial Operations (GCTO). The role will also contribute to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight ... and continuously monitored for effectiveness, efficiencies, and areas of improvement.Responsibilities: Clinical Trial Operational Risk (CTOR) Management:Build and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be ... Action/Preventive Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities: Clinical Trial Operational Risk Management:Own, lead and… 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)
- …if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Responsible for… more
- Merck & Co. (Philadelphia, PA)
- …strategic direction, and overall performance of the eSSC. Ensures sound clinical development principles are incorporated into the services provided by the ... leadershipExperience:- At least 10 years' experience in Operations and/or Research related fieldKnowledge and Skills:- Demonstrated excellent leadership and project… more
- Merck & Co. (North Wales, PA)
- …is collected from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse ... capability that focuses on technology/process simplification and innovation to:Improve the Clinical Trial experience for our patients.Improve efficiency of study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and ... of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process...including experience in one or more key functions (eg, clinical research , clinical operations, data… more
- Merck & Co. (Rahway, NJ)
- …in 47 countries, responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical Operations (GDO) department ... intends to:- Develop an understanding of the phases of clinical research -- Develop an understanding of the...tools critical to the oversight and conduct of a clinical trial - Participate in team meetings to… more
- Novo Nordisk Inc. (WA)
- …and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with ... The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing;...(NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or… more
- Insmed Incorporated (Bridgewater, NJ)
- …and Key Performance Indicators (KPIs). This role works closely with the Clinical Program Operations Leads, Clinical Trial Managers/Leads (US ... finalization of materials, and distribution to executive leadership.Manages vendor(s) for clinical trial data visualization dashboards to ensure accuracy of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …build 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical … more
- Merck & Co. (Rahway, NJ)
- …operating in 47 countries, responsible and accountable for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management ... intends to: Develop an understanding of the phases of clinical research . Develop an understanding of the...tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to… more
- Merck & Co. (North Wales, PA)
- …data collection is in alignment with the protocolCore SkillsWorking knowledge of clinical research regulatory requirements (eg, GCP and ICH)-Ability to manage ... management and prioritization skillsAnalytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… 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 ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees one… more
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring ... mentorship to other clinical scientists.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage… more
- Insmed Incorporated (San Diego, CA)
- …development of systems, practices, and procedures to ensure efficient and effective clinical trial execution including data management and analysis.Build and ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...trials at a Sponsor company.Experience managing various phases of clinical trials.Experience in global clinical trial… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Trial processes, GCP and applicable clinical research -related regulations.Solid track record of initiating, planning and delivery ... Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives.... Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead… more
