- Genmab (Plainsboro, NJ)
- …Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project/ Trial ManagementObtain Project/ Trial specific information to initiate drug supply ... scenarios) that may impact clinical drug supply)Create and maintain program/project and trial IMP/AMP forecast and demand plans throughout the trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in ... compliance. Proactively track, monitor and report trial risks, progress/performance, timelines, and financial metrics on an ongoing basis to study and program teams.… more
- Genmab (Plainsboro, NJ)
- …with several internal and external stakeholders, including GCDS Operations, GCDS Systems , Development Operations, Portfolio & Project Management, and CMC. You are ... an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a natural part… more
- Aequor (South San Francisco, CA)
- …the Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high-quality clinical trial data insights and to offer ... solutions necessary for RBQM implementation within Roche/Genentech, including in-house systems and potential external technologies. Support RBQM Strategic Leads and… more
- Merck & Co. (Rahway, NJ)
- …chain across the full of our 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...partners and senior leaders. Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Genmab (Plainsboro, NJ)
- …play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials. In addition, this position offers ... a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical Drug Supply Planning team.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process.Working knowledge of MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding tools is a preferred Daiichi ... of Data Management coding documentation and approval/signatures forms in the TMF ( Trial Master File) on an ongoing basis according to applicable Daiichi Sankyo… more
- Merck & Co. (Rahway, NJ)
- …platformTransform the way we conduct our clinical trials.Improve the clinical trial experience for our patients.Improve efficiency, reduce cycle time and enable ... Management supporting Information Technology, or Pharmaceutical Research or Clinical Trial Operations or Business Management3+ Experience working with agile… more
- Merck & Co. (North Wales, PA)
- … programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Designs and develops complex programming algorithms.Ability ... and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering… more
- Merck & Co. (North Wales, PA)
- …trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering… more
- Merck & Co. (Rahway, NJ)
- … system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle time, cost/size ... on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging capabilitiesResponsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and Canada as well ... development, effective execution of CMR role-specific/technical training (eg clinical trial -related, patient safety, therapeutic area leads, MSLs etc.) across the… more
- Genmab (NJ)
- …planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end ... support the efficient and effective execution of clinical trials.Ensures trial related data management activities (including planning, data collection, data… more
- Insmed Incorporated (Chicago, IL)
- …Clinical Operations, and Medical Affairs Departments. This may include trial site identification, ongoing recruitment motivation, and issue/problem solvingProvide ... and education to health care customers within managed markets/healthcare/payor systems , in addition to other unique healthcare influencers.Full support and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cohesiveness across SOPs and related documents related to clinical trial execution.Responsibilities:Development SOP Landscape Develop and maintain overview of ... guidelines governing clinical trials preferredUnderstanding and experience with end-to-end clinical trial processes and functions including experience in one or more… more
- Merck & Co. (Rahway, NJ)
- …PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems ... documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory meetings.Mentoring… 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 to ... & Microsoft PowerApps.- - Works directly in the SAP system to ensure a robust and consolidated forecast for...management. - Technical Proficiency: f amiliarity with supply chain systems and software ( eg SAP or Oracle) and… more
- Merck & Co. (Rahway, NJ)
- …of external data to the primary database or data warehouse systems .- Innovative Process Development:-Drive the development and implementation of innovative processes ... to enable paperless studies through an Electronic Data Capture system .- Stakeholder Collaboration:-Foster cooperative relationships with a diverse range of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to regulatory correspondences relating to NDAs, ANDAs, 505(b)(2) filings, clinical trial work, in multiple jurisdictions, specifically with FDA, EU, and MHRA. ... quality holds, equipment on-boarding, facility expansions, and using modern quality systems such as VEEVA, LIMS, SAP. Maintain current and thorough understanding… more
- Merck & Co. (North Wales, PA)
- …a global basis. We are responsible for negotiating industry sponsored clinical trial agreements, confidentiality agreements, and other type of agreements related to ... global improvement projects, identify and propose improvements to the internal systems or processes to ensure high compliance and efficiency standardsSupport… more
