- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in a pharmaceutical, biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, hands-on ... an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for… more
- Merck & Co. (North Wales, PA)
- …database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol-deviations in collaboration with the Clinical ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety ... post-doctoral fellows. Provides guidance, and mentors and coaches junior Clinical Safety Scientists.Responsibilities Risk Management (Signal identification,… more
- Merck & Co. (Rahway, NJ)
- …analysis and reporting deliverables for clinical trial projects ( data , analyses, tables, graphics, listings)Strong project management skills; leadership ... clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.- Responsibilities… more
- Merck & Co. (North Wales, PA)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management , and ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Merck & Co. (Rahway, NJ)
- …Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global... Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development… more
- Aequor (Thousand Oaks, CA)
- …to document, investigate, and communicate decisions concerning distribution complaints. Sales Order Management : - Create and manage Clinical Drug Shipments in an ... Data Review and Assessment: - Review the temperature data from shipments to clinical sites -...Systems (QMTS) Smartsheet and SharePoint knowledge General knowledge of clinical supply chain management Competencies: - Customer… more
- Merck & Co. (North Wales, PA)
- …team members when opportunities arise. Primary Activities :Programmatically synthesize preclinical / clinical data into analysis ready structures from varied ... developing analysis and reporting deliverables for Research &Development projects ( data , analyses, tables, graphics, listings)Strong project management skills;… more
- Merck & Co. (Rahway, NJ)
- …Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Catalent (Emeryville, CA)
- …favorably considered.Candidates should have skills that enable problem solving, data management , effective communication, and collaboration within ... Research Associate II, BioconjugationPosition Summary:Catalent Pharma Solutions in Emeryville,...conjugation chemistry and proprietary, stable linkers. SMARTag is a clinical -stage technology that was named Runner Up for Best… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals. Gather input from clinical and regulatory teams to understand clinical data / patient outcomes, identify market opportunities, address regulatory ... product potential Project Management and Coordination Support: Assist project management efforts to coordinate transition between clinical development and… more
- Merck & Co. (North Wales, PA)
- …to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, listings)Strong project management skills;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence (CDSE) - RWE team. 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … across internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... 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. (North Wales, PA)
- Job DescriptionWe are currently recruiting for the position of Associate Director, US Oncology - Hematology Scientific Strategy. This talented individual will lead ... a robust scientific leader (SL) engagement plan, coordinating with medical affairs, clinical research, and global marketing to provide a consistent One our Company's… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and coding library management .Manages, reviews and approves medical coding of clinical data ensuring high quality; creates and manages the synonym-lists to ... drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Merck & Co. (North Wales, PA)
- …of the role Preferred Experience and Skills: Ability to translate science/ clinical data into clear marketing strategies, medical education and/or ... processes) including experience including bringing materials through legal, regulatory, and clinical review Strong project management skills as demonstrated by… more