- Merck & Co. (Rahway, NJ)
- …to drive data excellence and enhance the efficiency of our clinical research operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct ... experienced Associate Director in Data Management to lead our data management team ...maintenance of comprehensive databases designed to collect and retain clinical data pertinent to laboratory challenges and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading & delivering… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …enhance standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards ... Job DescriptionThe Global Clinical Data Standards Vocabulary Specialist, Associate...able to:Work independently, collaboratively as a member of a team , or successfully as a leader, with equal effectivenessInteract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Genmab (Plainsboro, NJ)
- …CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology strategies ... the time in Princeton, NJResponsibilitiesBuild, oversee and lead delivery of pre- clinical and clinical pharmacology team across programs/processes around… more
- Insmed Incorporated (San Diego, CA)
- …to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team , partnering closely with heads of clinical ... plans and manuals in a cross-functional team .Supporting or preparing data interpretation and clinical trial reports.Preparing Investigator Alert letters and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs...the field of Thoracic Oncology .The Executive Director, PDT Lead will manage the entire cycle of clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for governance interactions. Independently manage interactions with clinical leads, data management, safety, regulatory, and QA team members, both internally ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...study progress and surveillance of key efficacy and safety data points. Collaborate with other functions (at CRO or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team , and be responsible for ... this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics,… more
- Genmab (Plainsboro, NJ)
- …seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team .As Senior Clinical Drug Supply Manager ... to drive solutions and inspire others.You will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Genmab (Plainsboro, NJ)
- …inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply Team discussions.Change and Stakeholder ... experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply (GCDS) Planning Team in Princeton and Copenhagen within commute… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(ECH) in collaboration with Employee Experience (EE)/P&O NAO and Global onboarding initiatives Lead a team of Role-Specific Training Support Partners to ensure ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Aequor (South San Francisco, CA)
- …CA Duration : 1 year The Position: The mission of the Data Intelligence team in the Early Clinical Development (ECD) department is to optimize the support of ... and conduct predictive analysis to increase the efficiency of clinical data review and clinical ...Management (RBQM) Data Analyst sits in the Data Intelligence team and supports ECD study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ... to achieve business objectives. It requires extensive knowledge of clinical data programming, external data ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outcomes Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing ... development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research...our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative ... 15 E- Maintains detailed Solution Architecture diagrams for ALL systems, integrations, and data flows. Work with the Enterprise Architecture team to ensure all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leadership Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to ... on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring...based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,… more
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