- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data . Lead the statistical support for ... signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant… more
- Eisai, Inc (Nutley, NJ)
- …and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of ... your profile, we want to hear from you. The Associate Director, Clinical Programming must have expertise...manages and oversees JReview and SAS program development for clinical data processing, data review… more
- Genmab (NJ)
- …as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Merck & Co. (Rahway, NJ)
- …Skills:Applied Engineering, Applied Engineering, Chemical Engineering, Chemistry, Clinical Operations, Customer-Focused, Data -Driven Decision Making, ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process… more
- Merck & Co. (Durham, NC)
- …the Master Data team with general Material Handling Steward tasksDrive safety , quality and process enhancements throughout the supply chain - Project Management ... DayValid Driving License:NoHazardous Material(s):n/aRequired Skills:Business, Business Processes, Capital Planning, Clinical Supply Chain Management, Communication, Customer-Focused, Data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead ... support safety signaling detections and across compounds safety reviews (ie, ILD). Collaborate with Clinical ...(ie, ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance Qualifications:… more
- Eisai, Inc (Exton, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and ... new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting… more
- Merck & Co. (Rahway, NJ)
- …(API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety , Interpersonal Relationships, ... enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases, preferredFamiliarity with Good ... processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow plan / data… more
- Merck & Co. (Rahway, NJ)
- …opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, ... will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally and across… more
- Eisai, Inc (Phoenix, AZ)
- …decision-makers through understanding of issues and opportunities in territory. Deliver clinical , efficacy, and safety messaging and information about product ... Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior for cleaning… more
- Mount Sinai Hospital (New York, NY)
- Job Description The Clinical Research Associate I monitors all aspects of clinical research trial(s) Clinical study life-cycle responsibilities including ... clinical study for the identification and evaluation of safety issues and any patterns that are identifiable. Reports...studies as a clinical trial assistant or clinical research associate is highly desirable. About… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …materials for study-wide meetings (eg investigator meetings, interim update meetings, data safety committee meetings, etc.) Perform QC (formatting, spelling ... new therapies to patients in need. The Position The Clinical Research Associate (CRA) provides support to...updates are reflected on ClinicalTrials.gov or equivalent Perform periodic data reviews as requested by Study Lead Prepare and… more
- Ascension (Wichita, KS)
- …skills and competencies. Support clinical leaders in aggregating and interpreting various quality/patient safety data with a focus on using data to drive ... and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make...clinical leaders in aggregating and interpreting various quality/patient safety data with a focus on using… more
- WorldLink (Mountain View, CA)
- Job Description TITLE: Clinical Research Associate (Digital Health) POSITION TYPE: Full Time (W2) LOCATION: Mountain View, CA (Candidates located in San ... visit https://worldlink-us.com . WHO we're looking for: We are looking for a Clinical Research Associate (Digital Health) who will be responsible for overseeing… more
- FocusKPI Inc. (Mountain View, CA)
- FocusKPI is looking for a Clinical Research Associate to join one of our clients, a high-tech SaaS company. Work Location: Mountain View, CA; hybrid role ... statistics and physiology Top 3 Skills for an ideal person: Human subject research ( data collection on subjects, clinical research in universities), clinical … more
- Holy Cross Hospital (Fort Lauderdale, FL)
- …the investigators in evaluating, documenting, and reporting adverse events and other safety related data . Conduct telephone screening calls for patients ... Purpose: This person will be responsible for the conduct of multiple Oncology clinical research activities. Ideal candidate will have industry sponsored clinical … more
