- Merck & Co. (Rahway, NJ)
- …experience in clinical data management.Knowledge and Skills:-Understanding of the clinical research process with in-depth knowledge of the Clinical ... Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials ...requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials , including but not limited to:...and timely execution and delivery of deliverables at the trial level. Primary activities include, but are not limited… more
- Merck & Co. (Rahway, NJ)
- …limited to:Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks ... Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we… more
- Merck & Co. (North Wales, PA)
- …business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation & Adaptive ... of working to manage risk and central analytics and ensure exquisite oversight of our clinical trials . It is also business critical the integrity of data is… more
- Merck & Co. (Rahway, NJ)
- …and our company's Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for clinical ... activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results in areas of… more
- Eisai, Inc (Nutley, NJ)
- …have the following responsibilities: Perform integrative analyses of multi-omics data from clinical trials and research cohorts, including genomics, ... will be focused on the bioinformatics collaborations in Oncology clinical trials and will thus play a...7 years of experience in the pharma industry or clinical research institution is required. Proficient in… more
- Aequor (South San Francisco, CA)
- …to elucidate the mechanisms underlying toxicities that are observed non-clinically and/or in clinical trials through hypothesis driven research . This process ... Toxicology Group within the department of Safety Assessment in Genentech's Research and Early Development organization. The mission of the Investigative Toxicology… more
- Eisai, Inc (NJ)
- …oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional service ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management;… 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 ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... Job DescriptionThe Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional...management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written… more
- Merck & Co. (Rahway, NJ)
- …and other company Research Laboratories Scientists in designing and analyzing clinical trials , and in coordinating the statistical activities for clinical ... problems arising in the design, conduct, and analysis of clinical trials , proposes solutions and carries them... activities for innovative statistical methods and applications in clinical trial development.-Mentors and guides junior staff… more
- Merck & Co. (Rahway, NJ)
- …Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ... and our company's guidelines and SOPs.Required Experience:5+ years of work experience in pre- clinical and/or clinical research to include minimum 2 years'… 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 ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… 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 ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...More Years with PharmD/PhD preferred Experience considered relevant includes clinical or basic research in a Pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Drafts development… more
- Lundbeck (MA)
- …therapeutic area strategy and tactics Liaise with study teams to direct MSL support for clinical trials and serve as the point of contact for dissemination in ... distillation, and reporting Understanding of the neurology therapeutic space, clinical research processes, and regulatory guidelines Strong interpersonal… 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 ... research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or equivalent… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Job DescriptionThe Biologics Analytical Research & Development department of our company's ...the group Director to define group strategy and to lead a team of scientists in solving complex analytical… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred- 7 or More Years proven… more
