- Insmed Incorporated (Bridgewater, NJ)
- …the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ... status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual...process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials ; Reviews regulatory documents from cross functional, holistic ... regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project;...representative or IST leader on study team; Responsible before senior management for the creation and execution… more
- Merck & Co. (Rahway, NJ)
- … Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials , including but not limited ... level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations line management experience Domestic and international clinical trial execution experience required Post-approval clinical ... drug development across projects Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators In… more
- Merck & Co. (Rahway, NJ)
- …oral and written reports to effectively communicate results of clinical trials to the project team, Company Management , regulatory agencies, or individual ... Management , and other Company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, ... of those principles to trial design, planning & conduct of clinical trials Deep understanding of Distributor, Logistics and Demand Planning Operations,… more
- Merck & Co. (North Wales, PA)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team...trial team (CTT) lead. -Leads team for timeline management , risk identification and mitigation, issue resolution.- May facilitate… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or solutions to mitigate or resolve, for example across various topics, such as clinical trial management , deviation handling, and product quality Develop, ... quality system Conduct GxP quality visits at clinical trial sites when directed by management to check principles of assuring patient safety, data integrity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates… more
- Merck & Co. (Rahway, NJ)
- …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life… 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 ... and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject… 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 ... components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people … more
- Catalent (San Diego, CA)
- …Communication and escalation of quality issues to Site Leadership Team and QA senior management .Lead programs for: QA department budget, Site Training, Supplier ... Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site...sizes to advance new medicines from early development to clinical trials and to the market. Catalent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking ... around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study… more
- Merck & Co. (Rahway, NJ)
- …to collaborate and consult on research projects, including market support studies, clinical trials , grant programs, and pre- clinical development of ... Job DescriptionThe Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the… more
- Aequor (Thousand Oaks, CA)
- …better, can be a hands off leader, candidates who have familiarity with Pharma; Clinical Trials . Qualities an ideal candidate possess that will work well with ... top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills such as lean… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... an in-house Medical Affairs role. Clinical research experience, including conducting clinical trials in the Phase IIIb-IV area. Experience reviewing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliver a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
