- Novo Nordisk Inc. (Plainsboro, NJ)
- …such as Data Science, serving as a key contact point into the Clinical Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one... Senior Manager reports directly to a Senior Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global ... healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to… more
- Merck & Co. (North Wales, PA)
- …SummaryThis position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the ... management, communication, and collaboration skills in support of our clinical trials.Job ResponsibilitiesResponsible for the operational planning, feasibility, and… more
- Merck & Co. (North Wales, PA)
- …may include (but is not limited to) the implementation of primary data collection, chart review/survey, database studies, health economic model development and ... Outcomes Research, V&I GMSA, BARDS HEDS, and others as determined by senior leadership by providing overall operational support for research conducted in compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the Biostatistics ... various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data . Work closely ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Aequor (Newbury Park, CA)
- …- both oral and written. Ability to understand and communicate scientific/ clinical information, Organizational skills. Knowledge of clinical regulatory ... Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory documents. Technical:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
