- Eisai, Inc (Nutley, NJ)
- …the programming team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards, eg, InForm, ... relational Databases, Oracle, SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems… more
- Eisai, Inc (Nutley, NJ)
- …an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ ... management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical… more
- Eisai, Inc (Nutley, NJ)
- …Proven experience in running clinical studies with an understanding of Clinical Operations and Data Management preferred. Significant experience working ... clinical research strategies, designing and providing oversight of clinical programs.Demonstrated experience in stakeholder management , vendor management… more
- Merck & Co. (North Wales, PA)
- …data collection in alignment with the protocol in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical ... clinical outcome assessments, biomarker sample collection and management , and external data monitoring committee.Managing other... Clinical Testing, Clinical Trial Compliance, Clinical Trial Management , Communication, Data … more
- Merck & Co. (Rahway, NJ)
- …and information into simple readable formSolid project management skillsFamiliarity with clinical data management conceptsStrategic thinking - ability to ... Material(s):N/ARequired Skills:Business, Business, Clinical Data , Clinical Databases, Clinical Site Management , Clinical Testing, … 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 ... Clinical Trial Designs, Clinical Trials, Cost Management , Creativity, Data Management , Geography, Initiative Activity, Leadership, Lean Process… more
- Merck & Co. (North Wales, PA)
- …to be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM ... 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Business, Communication, Data Management , Data Modeling, Numerical… more
- Merck & Co. (North Wales, PA)
- …ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Biostatistics, Clinical Development, Communication, Data ... Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers.Develops supplementary clinical data package in close partnership with markets and HTA… more
- Merck & Co. (Rahway, NJ)
- …Material(s):N/ARequired Skills: Clinical Site Management , Clinical Testing, Data Analysis, Data Management , Data Modeling, Development ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …Medical Affairs team. Direct education for healthcare professionals treating oncology patients on clinical data , adverse event management , and mechanism of ... between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education as… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory, Statistical Programming, Data Management and ... Requirements: 10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequired Skills: Data Management , Data Science, Numerical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ability to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management , Statistics). This position ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Merck & Co. (North Wales, PA)
- …Biopharmaceuticals, Biopharmaceutics, Clinical Reporting, Clinical Testing, Clinical Trials Analysis, Communication, Data Management , Epidemiology, ... and contribute to the value evidence plan and associated studies which demonstrate clinical , economic, and patient-centered value. The work will support one or more… more
- Merck & Co. (North Wales, PA)
- …Testing, Clinical Trial Management Processes, Clinical Trials Analysis, Data Analysis, Data Management , Data Science, Numerical Analysis, ... solid knowledge of statistical methodology, experimental design, computing software and data management ; a general understanding of worldwide regulatory… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the protocol in collaboration with Data Management /Programming. Collaborating cross-functionally to monitor clinical data -to ... Clinical Trial Compliance, Clinical Trial Management , Clinical Trials Analysis, Communication, Critical Thinking, Data Analysis, Drug Development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit ... checks, data quality listings, SAP, Data Management plan; Reviews patient population and...ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs… more
- Merck & Co. (Rahway, NJ)
- … Medicine, Clinical Neurophysiology, Clinical Research Management , Clinical Testing, Clinical Trial Development, Data Analysis, Decision Making, ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs,… more
- Eisai, Inc (Nutley, NJ)
- …of innovative strategies.Experience in managing and directing related functions such as data management , CRO vendor management , procurement, and ... development programs across different phases.The VP of Global Clinical Operations is responsible for the management ,...Global Clinical Operations is responsible for the management , oversight, and direction of the clinical … more
- Formation Bio (New York, NY)
- …sciences (biotech, pharma, or consulting) with at least 3+ years in people management Deep expertise in AI/ML for predicting biological/ clinical outcomes with ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Formation Bio (New York, NY)
- …efforts to ingest and transform unstructured and structured research, biomedical and clinical data into high-quality, actionable assets that power discovery and ... documents like clinical protocols and drug labels or building robust data pipelines that power operational and scientific decision-making, your work will sit at… more
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