- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates ... areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager ...strategic planning for future change. Subject matter expert on global clinical trial registration, result… 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 ... centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness...and mitigate clinical quality risk with the clinical trial teams during study start up,… 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, ... Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction...The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...in accordance with DS standards. Act as the project manager of the clinical study team to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …intellectually curious, join us-and start making your impact today.- - Overview:- - - Global Clinical Trail Operations (GCTO) is a global organization with ... responsible and accountable for the execution of the Merck clinical research portfolio. The Global Clinical...tools critical to the oversight and conduct of a clinical trial - Participate in team meetings to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...clinical studies, under the supervision of the Study Manager role the Study Associate Manager within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… 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), ... learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and… more
- Merck & Co. (Rahway, NJ)
- …are among the intellectually curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical ... preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds… more
- Merck & Co. (Rahway, NJ)
- …are among the intellectually curious, join us-and start making your impact today. -Overview: Global Clinical Trail Operations (GCTO) is a global organization ... stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives. You will be part...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle ... Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and...experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or… more
- Merck & Co. (Rahway, NJ)
- …Job Responsibilities: - Responsible for the operational planning, feasibility, and execution of a clinical trial .- May serve as the clinical trial ... Outlook, etc.).Preferred experience and skills: A plus with prior experience on managing global pediatric clinical trials (age 6 +), including managing central… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates ... centered around rare diseases and immune disorders. **Summary** The Clinical Trial Information Disclosure Manager ...strategic planning for future change. Subject matter expert on global clinical trial registration, result… more
- IQVIA (Newark, NJ)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor management ... becomes the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** ,...global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials....Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
