- Merck & Co. (Rahway, NJ)
- …in assigned studies.Escalates as needed different challenges and issues to TA Head/CRD Clinical Research Director /CCQM Country Clinical Quality Manager ... Trial Team-(as appropriate).Identifies and shares best practices across clinical trials , countries, clusters.-Responsible for collaboration with functional… more
- Merck & Co. (Rahway, NJ)
- … clinical trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - ... Job DescriptionThis role will be key to ensure strong monitoring in our clinical trials . Under the oversight of the CRD or Head of Site Management and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Merck & Co. (Rahway, NJ)
- … Director , Clinical Quality Management (RCQM), and in collaboration with the Clinical Research Director (s), the Sr CCQM Lead establishes and/or - ... Job DescriptionIt is critical that, for all company-sponsored clinical trials , patient safety, high quality...Clinical Trial processes, GCP and applicable clinical research -related regulations.Solid track record of initiating,… more
- Merck & Co. (Rahway, NJ)
- …and SAP team members to further extend capabilities and functionalities on our existing Clinical Trial Supply Management (CTSM) solution in order to satisfy and ... Management and Distribution areas with a strong focus in Clinical Trial Supply Management (CTSM) is highly...support of- SAP applications across all functional areas supporting Clinical Trials . This includes leading or contributing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical… more
- Tris Pharma (Monmouth Junction, NJ)
- …development plan for multiple, concurrent programs spanning all phases (I-IV)) of clinical research . The incumbent is responsible for establishing and overseeing ... and other existing/investigational products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and… more
- Tris Pharma (Monmouth Junction, NJ)
- … trials in multiple pain modelsProven record of success in Phase I-IV clinical research studies and trial design Detailed understanding of the ... (ie, substance use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards...company pain programDirects and oversees analysis and interpretation of clinical trial data and clinical … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
- Merck & Co. (North Wales, PA)
- …approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies. The Regional Medical Scientific Director serves ... and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential… more
- Insmed Incorporated (Bridgewater, NJ)
- … development experience in the pharmaceutical/biotech Industry. Previous experience conducting clinical trials in Dermatology is a plusWorking knowledge of ... our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1… more
- Merck & Co. (North Wales, PA)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …serving as the primary point of contact.- Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …4+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials , or academic clinical research background Working knowledge ... functional teams to support the design and execution of clinical trials , the drafting of medical/ scientific...Medical & Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research , Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical /regulatory documents Authors, reviews and/or edits documents to support clinical trials and regulatory submissions, which may include: Clinical ... medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA),… more
- Eisai, Inc (Nutley, NJ)
- …accordance with agreed to development plans and corporate objectives. Advanced understanding of clinical research and the clinical drug development process ... relate to efficient execution of the development plans. Advanced understanding of clinical trial management, including general understanding of all specialized… more
- Eisai, Inc (NJ)
- …therapeutic area and 3 years in an in-house Medical Affairs role; MD preferredClinical research experience, including conducting clinical trials in the Phase ... provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
