- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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. (North Wales, PA)
- …including data steps, procedures, SAS/MACRO, SAS/GRAPH and programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … 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
- Cedars Sinai (Los Angeles, CA)
- …improving patient outcomes. Are you ready to be a part of breakthrough research? The Clinical Research Associate I works directly with a Clinical Research ... protocol and research objectives. Responsible for completing case report forms, entering clinical research data , and assist with regulatory submissions to the… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …backgrounds, cultures, perspectives, and experiences to join our team. What You'll Do: The Associate Director, Clinical Data Management plays a key role ... drive timely, high-quality data delivery. This role reports to the Head of Clinical Data Management. Preferred location: Waltham, MA or San Diego, CA (onsite… more
- Cedars Sinai (West Hollywood, CA)
- …the world. Specimens have been collected from thousands of subjects over 3 decades. Clinical and research data are stored in an extensive database/LIMS system ... visit: MIRIAD IBD Biobank & Database | Cedars-Sinai. The Clinical Research Associate I works under the...guidelines. Primary Duties and Responsibilities: Collects, evaluates and/or abstracts clinical research data . May assist in designing… more
- Baystate Health (Springfield, MA)
- …quality and safety , is looking for a Part Time Operations Associate /Cardiac Monitor Technician to join our team in Springfield, MA. SCHEDULE: Part time, ... also as a business partner to the department and clinical staff. Orients patients and families to the unit,...transfers (ADTs). Coordinates unit/department ADTs. Checks BMD enters new data and advises Charge Nurse of changes. Checks CIS… more
- Pharmavise (Indianapolis, IN)
- …Our Fortune 500 Pharmaceutical client has an exciting opportunity for a Clinical Research Associate (CRA). Job Summary: The Clinical ... exceed their compliance goals while improving patient health and safety . Visit us at www.pharmavise.com and follow us on...business need for surge capacity coverage for delivery based Clinical Research Associate (CRA) roles. This surge… more
- Advocate Aurora Health (Aurora, IL)
- …issues and operational efficiencies. Distributes and discusses productivity reports and Clinical Integration reports. 10)Adheres to safety practices to maintain ... a safe work environment and promote patient safety . *Reports safety issues through established channels...ledger, OT-FTE report, etc.) 2)Maintains organized department records and data . 3)Maintains complete and accurate associate files… more
