- 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 ... strategic planning for future change. Subject matter expert on global clinical trial registration, result... pharmaceutical industry and in the area of clinical trial information disclosure highly desirable.1 or… 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 ... strategy, operations and execution related to eSSC services provided.Align with global /cross-functional leaders on strategic direction of assigned eSSC scope where… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree… 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, ... The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO,...and processes in industry setting requiredExperience considered relevant includes clinical or basic research in a pharmaceutical … 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, ... methods and processes in industry setting. required Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Novo Nordisk Inc. (WA)
- …of Washington DC or Baltimore, MD. Qualifications A minimum of 4 years of clinical trial experience within a pharmaceutical , biotechnology, CRO, and/or ... (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or...department, (subset of) NACD and/or as part of a global team and as aligned to a business case,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… 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...More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical … 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 ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Catalent (MA)
- …robust network built around flexible and integrated service offerings for pharmaceuticals in clinical trial phases I-IV. We provide reliable service and deep ... expertise in global supply chain and clinical supply management...not required.3 - 5 years of experience in contract pharmaceutical business with emphasis on clinical services.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferredOncology experience ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize ... established DS clinical data standards framework.Define, manage, and govern clinical data standards; Global Libraries, Standards Packages, Reporting Suites,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that Payer and KOL reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act as an ambassador to drive ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...for Brand planning and portfolio review- Provides input to Clinical on trial design, endpoints and comparators… more
- Eisai, Inc (Nutley, NJ)
- …relate to efficient execution of the development plans. Advanced understanding of clinical trial management, including general understanding of all specialized ... Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and...we want to hear from you. JOB SUMMARYThe Director, Clinical Project Management will manage assigned project (s), including… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation plans (CEP) and ... from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data...to detail to ensure the accuracy and consistency of clinical trial documents A strong foundation in… 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 ... degree + 5 years OR Master's + 3 years Pharmaceutical and/or clinical drug development experience OR...and skills: A plus with prior experience on managing global pediatric clinical trials (age 6 +),… more
