- Merck & Co. (Rahway, NJ)
- … Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical ... role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations,… more
- 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, project, and ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Merck & Co. (Rahway, NJ)
- …range of stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical Sub Team, Clinical Trial Team, ... improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide… 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, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… 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 ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… 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 ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… 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 ... with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… 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)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned ... scientific and clinical research knowledge is required. Strong understanding of clinical trial planning, management and metrics is essential as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data ... and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as...or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab… more
- Merck & Co. (Rahway, NJ)
- …clinical research experience. Related CR experience may include Clinical Trial -Assistant, Study Coordinator, Regulatory CTC or ... CRA/CRA and/or CRA Manager , acts as primary site contact and site manager -throughout all phases of a clinical research study, taking responsibility of… 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)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... 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. The GTL… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- Intra-Cellular Therapies, Inc (New York, NY)
- …results-driven individual to join our company, in the Clinical Operations Department as a ** Clinical Trial Manager /** **Senior Clinical Trial ... preferred + 4+ years in Clinical Operations is required; 2+ years as a Clinical Trial Manager + CNS experience is required + Must live in EST or CST… 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 ** , you'll play a key role in our clinical operations,… more
- Merck (Rahway, NJ)
- … Clinical Research, the individual is responsible to manage/oversee a team of CTCs( Clinical Trial Coordinator). As line manager the role is critical ... is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP...will work across the different country operations roles (eg CRM( Clinical Research Manager ), CRA( Clinical Research… more
