- 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and ... the writing of high-quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life… 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
- 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)
- …business information, Supply Chain, Finance and HR preferred- 1 or More Years Experience with Clinical Trials Data , Genomics and Bio Marker Data , Real World ... research areas centered around rare diseases and immune disorders. Job Summary: Data Engineer will partner with business stakeholders and decision makers to develop… 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
- Merck & Co. (North Wales, PA)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data ... from trial participants, in the right way to enable the Clinical Research to analyze data for efficacy, dosing, safety profiling and adverse events. The … 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the 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 ... other research areas centered around rare diseases and immune disorders. Summary The Director, Clinical Safety, will be a product safety lead or part of a product… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …across the organization. Minimum Job QualificationsLicensure or other certifications: Certified in Epic Clinical or Revenue Data Model or (or MUST be obtained ... of improving the health of our communities. About the Role:Job SummaryThe Manager- Data Engineering & Analytics is a highly skilled and experienced leader with… more
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