- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct ... regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted within clinical ...trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical ... clinical data to ensure quality, completeness, and integrity of trial conduct.Providing tactical/scientific mentorship to other clinical scientists.Core SkillsDemonstrated… more
- Genmab (NJ)
- …indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Merck & Co. (Rahway, NJ)
- …This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and interpretation -of clinical ... clinical data -to ensure quality, completeness , and integrity of trial conduct. Providing tactical/scientific mentorship to other clinical scientists. Core Skills… more
- Merck & Co. (North Wales, PA)
- …Responsibilities: Responsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial team leadMay lead team ... planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates,… more
- Merck & Co. (North Wales, PA)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Merck & Co. (Rahway, NJ)
- …across the full c ompany's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, packaging and ... spokesperson at clinical development related meetings (i .e., Clinical Trial Team s ) and product development related meetings...- Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional… more
- Formation Bio (New York, NY)
- …medical image analysis, focusing on MRI and X-ray modalities for clinical trial applications Design and implement automated image processing pipelines for disease ... endpoints Collaborate with clinical operations to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging… more
- Genmab (NJ)
- …compound lead, primarily up until proof of concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Merck & Co. (North Wales, PA)
- …for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team lead. Leads and ... subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management team . Review… more
- Merck & Co. (Rahway, NJ)
- …activities include, but are not limited to:-Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives ... Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address… more
- Merck & Co. (Rahway, NJ)
- …or related field plus 3 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied Mathematics, ... related field plus 5 years SAS programming experience in a clinical trial environment.Minimum requirement:Must have experience in CDISC SDTM and ADaM standards.Must… more
- Merck & Co. (Rahway, NJ)
- …field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field plus 3 years SAS programming experience in a clinical trial environmentDepartment Required Skills and Experience: Effective interpersonal skills and ability… more
- Merck & Co. (South San Francisco, CA)
- …strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across development ... of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. Represent QP2 on cardiometabolic and ophthalmology… more
- Merck & Co. (Rahway, NJ)
- …as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.Develops individual protocols and data analysis ... research activities for innovative statistical methods and applications in clinical trial developmentEducation & Skills Education and Minimum Requirement: PhD or… more
- Merck & Co. (North Wales, PA)
- …a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be sufficient ... and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff… more
- Merck & Co. (Boston, MA)
- …(PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), pediatrics modeling and disease progression modeling. In ... approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions Serve as a subject matter expert and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Merck & Co. (San Antonio, TX)
- …efforts to achieve study milestonesUpon request from Global Clinical Trial OperationsRecommends study sites and identifies potential investigators to participate ... study milestones.Protocol lead responsibilities in collaboration with Global Clinical Trial OperationsAddresses questions from investigators and provides information regarding… more
- Merck & Co. (Rahway, NJ)
- …Clinical Medicine, Clinical Research, Clinical Sciences, Clinical Testing, Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Data ... Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, Regulatory Requirements, Scientific Consulting-Preferred Skills:Colorectal Cancer, Hepatocellular Carcinoma (HCC)Job Posting End… more
