- Merck & Co. (North Wales, PA)
- Job DescriptionThe Senior Director, GCTO Project Management Office will report to the Executive Director, Head of the GCTO Project Management Office (PMO). ... and cost control. Monitor project financials and provide regular reports to senior leadership. Risk Management : Identify and mitigate project risks, proactively… more
- Merck & Co. (Rahway, NJ)
- …creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program.- Develops ... trial -level development forums.Under the guidance of more senior staff, may serve as the data management... outcomes assessments.2. Serves as project manager of all clinical data management activities for trials… 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 ... for the scientific aspects of the implementation and conduct of a clinical trial (eg, investigator meeting presentations, safety and medical monitoring)May… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all phases of the trial .Performs clinical study site management /monitoring activities in compliance ... and present technical information effectively.Excellent understanding and working knowledge of clinical research, phases of clinical trials , current… more
- Merck & Co. (North Wales, PA)
- …oral and written reports to effectively communicate results of clinical trials to the project team, management , regulatory agencies, or individual ... and other of our company's Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for … 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
- 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
- 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
- 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
- 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. (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
- Catalent (Manassas, VA)
- …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 ... Senior Quality Auditor Position Summary: Catalent is a...be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are… 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
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The ...sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management… more
- Eisai, Inc (NJ)
- …Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ; providing guidance ... Suite with a good understanding of other IT systems for contract management and clinical development.#LI-TS1Eisai Salary Transparency Language:The base salary… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He ... and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs… 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
- 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
- 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
- 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
