- Eisai, Inc (Nutley, NJ)
- …audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and ... an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research / operations/ data management or related area. 5+… more
- Merck & Co. (Rahway, NJ)
- …Skills:Adaptability, Adaptability, Business, Business Risks, Change Management , Clinical Development, Clinical Research , Cross-Functional Team ... desirable. - Preferred Experience and Skills: - - Proficiency in using supply chain management systems and software, including experience with ERP systems … more
- Merck & Co. (San Francisco, CA)
- …one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for ... partner with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- …needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally.Types of studies executed include prospective and retrospective ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… more
- Merck & Co. (North Wales, PA)
- …Material(s):n/aRequired Skills:Biostatistics, Clinical Development, Communication, Data Management , Epidemiology, Health Economics, Health Outcomes Research , ... Management Process, Marketing Strategies, Medical Affairs, Neuroanatomy, Outcomes Research , Pathophysiology, Pharmacokinetics, Researching, Social Collaboration, Stakeholder Relationship … more
- Merck & Co. (Rahway, NJ)
- …the clinical supply planning function. - Proficiency in using supply chain management systems and software, including experience with ERP systems (eg, ... clinical supply chain across the full c ompany's Research & Development Division portfolio of clinical ...SAP), demand planning tools, and inventory management systems . - Proven record in project / portfolio … more
- Merck & Co. (Rahway, NJ)
- …within the clinical supply planning function.-Proficiency in using supply chain management systems and software, including experience with ERP systems ... of project management and clinical customer relationship management .-Technical Proficiency: familiarity with supply chain systems and software (eg… more
- Merck & Co. (North Wales, PA)
- …ApplicableShift:Valid Driving License:Hazardous Material(s):Required Skills:Business, Data Management , Epidemiology, Health Economics, Health Outcomes ... the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based...Research , Health Sciences Research , Management Process, Medical Economics, Medical Teaching,… more
- Eisai, Inc (Nutley, NJ)
- … research strategies, designing and providing oversight of clinical programs.Demonstrated experience in stakeholder management , vendor management ... PhD's, reporting to this role. Responsibilities: Provide leadership and successfully manage clinical research programs, and key business objectives within the… more
- Eisai, Inc (Nutley, NJ)
- …the programming team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards, eg, InForm, ... Oracle, SQL, CDISC, and CDASH.Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.Strong… more
- Eisai, Inc (Nutley, NJ)
- … clinical development programs across different phases.The VP of Global Clinical Operations is responsible for the management , oversight, and direction ... This individual must effectively balance strategic vision with hands-on operational management strategies to expedite clinical operations activities. These… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of ...OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRTAssist with tracking SAE safety… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... 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
- Merck & Co. (North Wales, PA)
- …with scientific leaders, patient organizations, academic medical centers, health systems , research organizations, database holders, and others.To prepare ... outcomes research protocols, statistical analysis plans, and clinical study reports.To ensure findings are communicated effectively at scientific conferences, in… more
- Merck & Co. (Rahway, NJ)
- …Facilitate equipment/ system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & global ... (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). Troubleshooting ability (mechanical/electrical/automation) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Merck & Co. (North Wales, PA)
- …Algorithms, Applied Mathematics, Biostatistics, Business Process Improvements, Business Strategies, Clinical Development, Clinical Research , Clinical ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and ... high-quality products, test methods, and robust manufacturing processes for both clinical and commercial use. This position interacts extensively with subject-matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management support regarding compliance concerns identified during internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The… more
- Merck & Co. (North Wales, PA)
- …managing any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Clinical Data, Clinical Operations, Clinical Research , Clinical… more
