- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of ... from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Teams...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Merck & Co. (Rahway, NJ)
- …in database entry systems.Strong knowledge of GCP and GLP.Thorough understanding of clinical research and clinical trial methodologies.Strong regulatory ... clinical trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity,… more
- Genmab (NJ)
- …area for one or more compounds in various stages of clinical development (including clinical trial implementation, and oversight of all aspects ... of clinical development ) working closely with the Medical Director and other...timely deliverablesResponsibilities Lead or co-lead one or more complex clinical trial (s) in a therapeutic area for… more
- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight ... portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data...and processes support the efficient and effective execution of clinical trials.Ensures trial related data management activities… more
- Merck & Co. (Rahway, NJ)
- …the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects ... Responsibilities: Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing critical questions for optimizing model-based… more
- Merck & Co. (Rahway, NJ)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming critical drug … more
- Merck & Co. (Rahway, NJ)
- …or related field plus 9 years SAS/R programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life ... Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In...7 or more years SAS/R programming experience in a clinical trial environmentRequired Experience and Skills: Excellent… more
- Genmab (Plainsboro, NJ)
- …to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, facilitate ... communication and resolve issues.Vendor Owner:First Point of Contact for clinical trial vendors: Serves as the first point of contact for the vendors, across… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .- The AVP provides strategic oversight for the early ... direction of clinical programs involving translational research and early clinical development for the Cardiovascular & Respiratory Therapeutic Area.- They… more
- Genmab (Plainsboro, NJ)
- …Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the ... authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... or university)- Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required Experience Qualifications- 2 or More… more
- Insmed Incorporated (Chicago, IL)
- …healthcare influencers.Full support and execution of Medical Affairs plans, Clinical Development projects, programs, and initiativesJob Requirements:An advanced ... synthesize and deliver HCP derived scientific insights to InsmedSupport research and development programs as requested by R&D, Clinical Operations, and Medical… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the ... of statistical datasets that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.The position is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... with regulatory agencies, including the FDA Experience with rare disease drug development , innovative trial design and/or expedited regulatory pathways, highly… more
- Merck & Co. (North Wales, PA)
- …and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... Job DescriptionRole SummaryThe Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD,...investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development , Clinical Scientists, Clinical ... or similar environment (eg, CRO) requiredOncology, immunology, or complex disease clinical trial experience preferredMust have a strong understanding and… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... & Development department of our Research & Development Division is seeking applicants for an Associate... Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New… more
- Lilly (Indianapolis, IN)
- …wage for this position is $63,000 - $140,800 **Purpose:** The Clinical Development Trial Leader (CDTL) Associate leads the cross-functional study team ... The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to… more
- Actalent (Boston, MA)
- Job Description The Senior Clinical Trial Associate (Sr. CTA) is responsible for supporting the daily workflow of clinical operations activities. The Sr. ... document filing, maintaining study trackers, and oversight of the study-specific electronic Trial Master Files (eTMF). Responsibilities + Serve as a member of the… more
