- 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 ... Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management , and Non- clinical Development. Essential Functions ... clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer...in the department General Tasks: Interprets and accurately presents clinical and statistical data in a clear,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, as well as building a network with key staff members including senior management , the global functional leads, Regulatory Intelligence, and Policy and ... external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data on the… more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Process/Facility Engineer include the following:The process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trials, or academic clinical research background Working knowledge of biostatistics, data management , clinical operations and scientific and technical ... inquiries Lend clinical expertise to the Statistical Analysis Plan development and data management , and work closely with statistical programming and data… more
- Merck & Co. (North Wales, PA)
- …lead team in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site ... PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or medical… more
- Merck & Co. (Rahway, NJ)
- …or supporting the QP2-I/O Function Lead on oncology development teams. Data management and analysis.On the job, working with senior scientists you will ... the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to … more
- Merck & Co. (North Wales, PA)
- …leadership and support for early-stage clinical oncology programs.Interact with Clinical , Regulatory, Statistical Programming, Data Management , and other ... way we approach serious diseases.The incumbent is responsible for statistical planning and data analysis of Phase I/II oncology clinical trials. This position… more
- Merck & Co. (North Wales, PA)
- …team in key study planning, development and execution elements (eg, data management deliverables, protocol level plans/timelines, country/site selection, system ... Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical... trial team (CTT) lead. -Leads team for timeline management , risk identification and mitigation, issue resolution.- May facilitate… more
- Merck & Co. (North Wales, PA)
- …of all Supplier documents such as monitoring, project management , safety management , data management and validation plans.Participate in protocol and ... exchange, improving access and health outcomes for patients. The Research Management Operations team sits within the Real-World Evidence (RWE) Operations… more
- Merck & Co. (North Wales, PA)
- …as statistical support for translational oncology projects and studies.-Interact with Clinical , Regulatory, Statistical Programming, Data Management , and ... clinical trials as well as analyzing oncology biomarker and clinical data .-Coordinate all statistical activities for ongoing clinical projects.Education… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …etc.) preferred Experience Qualifications- 10+ years of previous experience at senior management level leading quality organization and demonstrated track ... team (global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement ... studies in one or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and… more
- Eisai, Inc (Nutley, NJ)
- …and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs ... for the therapeutic area. Communicate and represent these plans to upper management / senior leadership. Continuously update plans and inform stakeholders of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionGlobal Senior Director Medical Affairs (GDMA) - Daiichi Alliance, OncologyThe Global Senior Director Medical Affairs (GDMA) is responsible for ... and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global Human Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as ... around rare diseases and immune disorders.Summary The Manager / Senior Manager, Data Programmer is a member... data review listings and reports to support Data Management and clinical teams.Develop,… more
- Insmed Incorporated (Bridgewater, NJ)
- …to contract research organizations. Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on ... teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the… 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 ... communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Aequor (Newbury Park, CA)
- …in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems, SharePoint sites ... - both oral and written. Ability to understand and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory… more
