- Novo Nordisk Inc. (Los Angeles, CA)
- …clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …File (TMF) and assist with periodic audit of the TMF Drive critical clinical trial activities including trial site activations, recruitment, and database lock ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Central Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables ... of QTLs and visualization/tabulations to detect data oddities, trends, or when site (s) are potentially under/over reporting clinical outcomes (eg, earlier/later… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...a timely manner and with quality (eg communication plan, site monitoring plan, etc.) as per study plan.Responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Experience in managing/monitoring clinical research sites (in-house or on- site ) prior onsite ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...projects for CDO & Novo Nordisk (eg Investigators and site staff, Health Systems, Contract Research Organizations and … more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities within the Atherosclerosis and Metabolism therapeutic area, ... - The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle management activities in ... organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our ... company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development, and life-cycle management ... individual will be responsible for overseeing Product Development Team Leaders and- Clinical Directors within their group to ensure successful execution of programs… more
- Merck & Co. (Rahway, NJ)
- …lead our data management team in supporting the pharm and vaccine veterinary clinical trials. The ideal candidate will be responsible for overseeing the development ... and maintenance of clinical databases and ensuring the integrity, consistency, and confidentiality...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …diversity, equity, and inclusion objectives. The program provides in-depth exposure to clinical drug development with emphasis on key elements of clinical ... trial planning, execution, data analysis and reporting of clinical trial results. Physician Scientists will develop skills working...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...plan agreed to by the Global Project Team (GPT).Lead site selection and site qualification discussions, kick-off… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work...as Risk Assessment Categorization Tool (RACT) Ensure country and site selection meet study requirements. May review critical study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled Terminology and applying ... growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards development teams and data governance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met...projects for NACD & Novo Nordisk (eg Investigators and site staff, Health Systems, Contract Research Organizations and … more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials....position will be based in our Copenhagen or Princeton site , which require onsite presence 60% of the time… more
- Insmed Incorporated (San Diego, CA)
- …clinical quality, and biostatistics.Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, ... and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical … more
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