- Merck & Co. (North Wales, PA)
- …standard collection and mapping data definitions aligned with industry Clinical Data Interchange Standards Consortium (CDISC) standards and Health Authority ... the definition of maintenance of additional standards library componentsParticipate in standards data governance reviewsThe Global Clinical Data Standards… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager, Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global ... Clinical Data Standards (GCDS)...productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data … more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a ... for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data… more
- Icon VendorPass and Affiliates (Waltham, MA)
- Position Title: Clinical Data ScientistLocation: Waltham, MaPay Rate: $60/hr (+benefits)Assignment Length: 1-year W2 ContractSchedule: HybridIndustry: ... Pharmaceutical JOB OVERVIEWTowards Integrated workflows & Data collection Work hands-on with R&B Scientists & technicians...Scientists & technicians in specific sites to upgrade current data operations and practices to build impactful ways of… more
- Tris Pharma (Monmouth Junction, NJ)
- …FUNCTIONS Actively participates in, or leads various aspects of preclinical or clinical data review including, but not limited to: adverse events, ... analysis plans, data management and safety management plans Ensures clinical data collection proceeds in a manner consistent with strategic objectives and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical... Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical ... Management, is accountable for an end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical... data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical company, or ... Management, is accountable for the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical... data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesManage external vendors ... complex data review listings and reports to support Data Management and clinical teams.Develop, implement and maintain SAS programming standards and performs… more
- Atlas Data Systems (Boston, MA)
- …materials, follow-ups, etc. Job Requirements Qualifications & Experience: Proven experience with Clinical Data , Modeling, and Simulation domains. A minimum of a ... the area of Computer Science, Data Science Strong and Relevant Clinical Data experience 10+ years of Project Management experience is required EST required.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Careerbuilder-US (Atlanta, GA)
- … and scientific research methodologies to generate research questions, query complex clinical data to conduct descriptive and predictive analysis that create ... leveraging graphs, and other visualizations to enable rapid understanding of clinical data to deliver business insights. * Ability to evaluate, interpret &… more
- Eisai, Inc (Nutley, NJ)
- …responsibilities.Ensures the timely and appropriate collection, organization, and analysis of diverse data sources (eg, clinical trial data , patient ... understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliver foundational data capabilities like Data Lakes, Master Data Management, NLP Integrations etc. for Clinical , Regulatory & Translational Research. ... experience preferred- 4 or More Years 3 + years of experience with Clinical Trials Data , Genomics, Bio Marker & Regulatory Data preferred- 4 or More… more
- Arthrex (Naples, FL)
- …study-related needs Assist with site training for protocol, eTMF, and EDC for data collection clinical research initiatives Facilitate preparation of pending ... development is preferred.Machine, Tools, and/or Equipment Skills:Experience in Microsoft Office, Clinical trial Electronic Data Capture systems, is required.… more
- Russell Tobin & Associates (Minneapolis, MN)
- …with healthcare administrative data , including claims and enrollment. Familiarity with clinical data domains and code sets (eg, CPT, ICD, DRG). Russell ... What are we looking for in our Senior Provider Data Anlyst? Location: Remote/Telecommute Duration : 6+months Pay :...to continuous improvement in our processes and the provider data we deliver to our members. Collaboration is at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key ... around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic… more
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