- Parexel (Olympia, WA)
- …of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety ... medical safety expertise to client per request + Review and sign off Data Management line listings (including adverse events, laboratory data , vital signs… more
- Sanofi Group (Cambridge, MA)
- …and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information ... Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other...experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an… more
- Astellas Pharma (Northbrook, IL)
- …phase or novel asset or represent Astellas on statistical matters related to safety data , clinical data , Biomarkers, PK/PD, PROs, or methodology at meetings with ... train other statisticians. **Essential Job Responsibilities:** Provides best in class safety data science and statistical support to the asset level for Astellas… more
- Sanofi Group (Morristown, NJ)
- …and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information ... in the Study team, ensuring the medical relevance of the clinical data + Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements to ensure that the analysis plans use the most ... appropriate statistical methods and that the data displays such as tables/figures/listings are accurate and complete....statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry + Experience in Phases I-III of the… more
- Charles River Laboratories (Wilmington, MA)
- …metrics. + Provide regular reporting to HR leadership and stakeholders to support data -driven decision-making. Compliance & Data Security + Ensure the Neocase ... system complies with organizational policies, data privacy regulations, and security standards. + Support audits...River** Charles River is an early-stage contract research organization ( CRO ). We have built upon our foundation of laboratory… more
- Johns Hopkins University (Baltimore, MD)
- …trials. + Collaborates in the design of appropriate methods for collection of data required for assigned trials. + Oversees & collaborates in development of study ... tools including data collection forms, eligibility checklists, preprinted orders, & distribution...sheets for pharmacy and assures submission of same to CRO /IRB for assigned protocols as appropriate. + Monitors for… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …final protocol and protocol amendments. + Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality ... data for database locks and interim cuts. + Serves...A minimum of 3 years in a pharmaceutical industry, CRO , or other health related scientific field; planning/managing clinical… more
- BeOne Medicines (San Mateo, CA)
- …resource planning and tracking. + Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical ... key study-related documents produced by other functions, eg SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans… more
- Charles River Laboratories (Rockville, MD)
- …a career that you can feel passionate about. **Job Summary** The Quality Control (QC) Coordinator is a key administrative and logistical support role within the ... Quality Control department, ensuring the efficient and compliant management of...and compliant management of all product samples and associated data . This position serves as the central point of… more
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