- Merck & Co. (Durham, NC)
- …Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.Must demonstrate strong leadership skills, and good oral and ... in the biopharmaceutical fieldExperience with GMP compliant calibration and/or maintenance database systems.Knowledge of SAP and Allen Bradley PLC's, Siemens Apogee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance of the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after database lock.Oversee CRO ... study close-out activities (including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed.Support Department in codifying existing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance of the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after database lock.Oversee CRO ... study close-out activities (including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed.Knowledge Management/People… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …job skills: Experience in solution design, data management, data integration and database development techniques. Works in Agile solution delivery Experience in SQL, ... IQVIA, Veeva, Customer or Product Master Systems Knowledge of Snowflake Database , Tableau, QlikSense and Informatica Experience in handling onsite/offshore team… more
- Merck & Co. (Rahway, NJ)
- …tools to analyze and interpret data for process improvement, including database querying and data programming.Ensure compliance with data integrity, CFR, ... GMP/regulations, and system life cycle documentation methodology specific to the pharmaceutical industry.Education Requirements:Bachelor's degree in: Engineering, Science, Information Technology, or related field (with expected graduation by August 2024).… more
- Merck & Co. (Durham, NC)
- …environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of sample and other materials as ... required to appropriate laboratories, coordinating with Quality and Logistics as required . - Attends and actively participates in safety & housekeeping, walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental… more
- Catalent (Emeryville, CA)
- …an accurate and up to date lab notebook and protein database .Proactively communicate results to team.Support cross-functional research activities.Assist team as ... needed by performing other related duties, such as formulation or stability studies .All other duties as assigned The Candidate: Bachelor's degree (BS) in Biology, Chemistry or a related discipline required with 1.5+ years of additional research experience in… more
- Merck & Co. (Rahway, NJ)
- …including data steps, procedures, SAS/MACRO, SAS/GRAPH, SAS systems and database expertise; designing and developing complex programming algorithms; comprehending ... analysis plans which describe methodologies to be programmed; applying clinical data management concepts; CDISC and ADaM standards; process compliance and deliverable quality; and developing analysis and reporting deliverables for Research and Development… more
- Merck & Co. (Rahway, NJ)
- …disclosure registry), the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) registry, and The Heads of Medicines Agencies (HMA)- European ... Medicines Agency (EMA) Catalogue of Real World Data (RWD) Studies (formerly EU PAS) registry for studies of varying complexity and therapeutic designation. Preparing study registration and results postings based on source documents (eg, protocols, CSRs),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as ... needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: Consults with internal experts and external KOLs for protocol development; provides input on CRO and ARO Scope of Work and budget;… more
