- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, ... Clinical Research, the individual is responsible to-manage/oversee a team of CTCs( Clinical Trial Coordinator).As line manager the role is critical to… 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, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Eisai, Inc (Nutley, NJ)
- …they relate to efficient execution of the development plans. Advanced understanding of clinical trial management , including general understanding of all ... this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on clinical programs in scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and ... centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management... Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who ... deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will… 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 ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… 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, ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …2 Studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates management on potential risks to ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliver a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus preferred ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Merck & Co. (Rahway, NJ)
- … Director ) as needed.Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, ... and ensures continuity of site relationships through all phases of the trial .Performs clinical study site management /monitoring activities in compliance… more
- Merck & Co. (Rahway, NJ)
- … Director ) as needed.-Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs,-pharmacovigilance, ... relationships and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management /monitoring activities in… more
- Merck & Co. (Rahway, NJ)
- …or related field plus at least twelve (12) years SAS programming experience in a clinical trial environment or a Master's degree (or its US equivalent) in ... or related field plus at least ten (10) years SAS programming experience in a clinical trial environment.Experience must also include at least seven (7) years of… more
- Eisai, Inc (NJ)
- … provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management , and functional area leads… more
