- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ultimate experience for our ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …workplace safety, managing our supply chain and sampling, supporting technological and data innovation , maintaining our facilities and assuring the integrity and ... complex business challenges.Engage senior leaders to drive strategic analytics transformations.Partner with Data Strategy , AI Engineering, and IT teams to ensure… more
- Merck & Co. (Rahway, NJ)
- …general direction of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead, the Senior Scientist has responsibility for coordinating global ... Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes...with and executed and interpreted to support the product strategy .Primary activities include but are not limited to:Provide assistance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ultimate experience for our ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.-Interacts with key partner organizations such ... business risks, & influence portfolio decisions with facts and data - Demonstrates ability to balance strategy ...Clinical Supply Chain Management, Clinical Testing, Clinical Trial Management, Cross-Functional Team Leadership, Data … more
- Merck & Co. (Rahway, NJ)
- …collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.-Interacts with key partners in both ... both technical & business risks, & influence portfolio decisions with facts and data -Demonstrates ability to balance strategy with ability for tactical… more
- Merck & Co. (Rahway, NJ)
- …both technical & business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution ... Business, Business Risks, Change Management, Clinical Development, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy : Provides the strategic direction to Biostatistics Data ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group...ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs… 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 PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical development systems, PV systems and MA systems including data management, statistical programming, digital technologies, and clinical ... Join a Legacy of Innovation - 125 Years and Counting!Daiichi Sankyo Group...across GxP (GCP/GVL/GCLP/GLP) systems.Lead the development of the global Data Integrity strategy and promote a quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Operations as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of ... rare diseases and immune disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety leadership and serving as the primary point of contact.- Review and analyze data from clinical trials, post-marketing and other relevant sources for the ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is...areas centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ultimate experience for our ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Lab Technology (MLACS-accredited), or NAACLS-accredited preferred Experience Qualifications - Clinical data management laboratory experience and strong knowledge ... tested in the oncology setting, latest and advanced analytical tools and assays. Clinical data management experience in a medical device, pharmaceutical company,… more
- Merck & Co. (New York, NY)
- …, including field standard operating procedures (SOPs), Good Clinical Practice (GCP) guidelines, and administrative/operational responsibilities. - Preferred ... applicable policies Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) - Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management, Statistics). This position requires skills ... areas to be improved and initiates rectification or remedial activities. Develops the strategy for technology and innovation to improve the overall efficiency in… more
- Merck & Co. (Rahway, NJ)
- …will be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and understanding the ... operations teams as they key liaison to enable implementation of precision medicine strategy in clinical trialsContribute to creation of translational plans for… more
- Merck & Co. (Rahway, NJ)
- …and information into simple readable formSolid project management skillsFamiliarity with clinical data management conceptsStrategic thinking - ability to turn ... 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Business, Business, Clinical Data , Clinical Databases, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group...CTA/CDx assays, prospective vs retrospective analyses and collection, missing data , demographic/representativeness of samples from clinical trial… more
- Merck & Co. (Rahway, NJ)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH;… more
