- Tris Pharma (Monmouth Junction, NJ)
- …quality-by-design in trial oversight and risk management across outsourced clinical trials , ensuring efficient issue resolution, risk mitigation and ... study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or... clinical operations function by outlining scope of clinical trial programs and aligning resource needs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics and Demand Planning Operations, ... deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will… more
- Eisai, Inc (NJ)
- …Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management; ... this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... in scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensures quality delivery of all 3rd party data from diverse external providers for clinical trials , companion diagnostics trials , clinical development, ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical … 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
- Merck & Co. (Rahway, NJ)
- …biopharma research, such as public Omics databases (eg, GenBank, GEO), clinical trial repositories (eg, ClinicalTrials.gov), patient-level data platforms (eg, ... Biotechnology, Cell-Based Assays, Cell Biology, Cell Physiology, Chemical Biology, Clinical Trials , Computer Science, Data Architecture, Data Integration,… more
- Merck & Co. (Rahway, NJ)
- …strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and summarizing ... clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these … more
- Merck & Co. (Rahway, NJ)
- …strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs;Analyzing and summarizing ... 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)
- …of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this ... requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Merck & Co. (Rahway, NJ)
- …or related field plus at least twelve (12) years SAS programming experience in a clinical trial environment or a Master's degree (or its US equivalent) in ... least ten (10) years SAS programming experience in a clinical trial environment.Experience must also include at...demonstrated ability to lead and develop people; expertise in managing and forecasting programming resources at the project and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
- Catalent (Harman, WV)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Position Summary The Director , Quality Systems is responsible for the management...substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and subsequent manufacturing… more
- Merck & Co. (Rahway, NJ)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director , is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience or equivalent required- Industry experience: Pharmaceutical, life science, clinical trials management, healthcare preferred- Project Management ... Execute with strong project management skills, including monitoring work-plans and managing against milestones, knowing what to prioritize and why, knowing who… more
- Catalent (CA)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an Account Director , Pharmaceutical Softgel and Late-Stage Oral Solids. This position will be… more
- Careerbuilder-US (Pittsburgh, PA)
- …interpret & synthesize scientific data, and to verbally present and critically discuss clinical trial and published data in internal and external meetings. ... analysis, and meta-analysis. The Data Scientist will work closely with the Director of Analytics & Informatics to develop and implement advanced analytics… more
