- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of charters for the Steering Committee (SC), Endpoint Committee , and Data Monitoring Committee (DMC). Identify committee members and ... the development of clinical sections of study-level documents (eg, protocol, amendments)- Reviews safety data to mitigate risk to trial participants for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Meeting- Develop and maintain programming macros to effectively support internal data review and monitoring . Responsibilities include: work with Biostatistics ... pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the...data review, develop macros and support the internal data review and monitoring on an ongoing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a culture of innovation across the whole organization, encouraging psychological safety and agile methodology to boost creative thinking and continuous improvement- ... enhance the understanding of business development opportunities offered by data science organization.- Build productive working relationships with key stakeholders… more
- Sutter Health (Novato, CA)
- …and other healthcare providers through competent patient assessment, attentive monitoring and care, and effective communication. Adheres to all local/state/federal ... regulations, codes, policies and procedures to ensure privacy and safety while delivering optimal patient care. May also be responsible for performing specific… more
- University of Colorado (Aurora, CO)
- …Program Director and Deputy Associate Director of Clinical Research. + Collaborates with the Data Safety Monitoring Committee , Protocol Review ... Director and Deputy Associate Director of Clinical Research. + Collaborates with the Data Safety Monitoring Committee , Protocol Review Monitoring … more
- University Of Vermont (Burlington, VT)
- …it relates to Investigator Initiated Trial ( IIT ) data and the Data Safety Monitoring Committee ( DSMC ). Minimum Qualifications (or equivalent ... Position Details Advertising/Posting Title Data Management Specialist Diversity Statement The University is...how they will further this goal. Posting Summary Ensure data for oncology clinical trials is accurate, complete, and… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …audits with clinical trials monitors, FDA inspectors, NCTN auditors, quality management, data safety and monitoring committee and Emory CTAC + Ensures ... or an equivalent combination of education and experience. + Experience in electronic data capture (EDC) systems and clinical trials monitoring systems (CTMS)… more
- Weill Cornell Medical College (New York, NY)
- …Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC), and other regulatory ... + Develops and implements a project-specific monitoring plan. Performs remote monitoring visits to review data timeliness and accuracy. + Issues queries… more
- BeiGene (San Mateo, CA)
- … safety contents and contribute to Data Monitoring Committees or Safety Monitoring Committee . + Lead signal detection and related tasks which are ... authoritative and professional member of relevant teams. Leads signal evaluation/ safety monitoring activities and contributes and assists... Data Management to ensure that outputs of safety data from both safety … more
- University of Colorado (Aurora, CO)
- …appropriate parties, eg Principal Investigator, Study Sponsor, FDA, Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator. + Serves ... parties, eg Principal Investigator, Study Sponsor, FDA, Data and Safety Monitoring Committee (DSMC), Regulatory Affairs Coordinator. + Serves as a… more
- University of Utah (Salt Lake City, UT)
- …guidelines. 2. Compile comprehensive reports for Principal Investigators, the Data and Safety Monitoring Committee ( DSMC ) and other committees as ... on the protocol and acting as a liaison to the Data and Safety Monitoring Committee . This job description has been designed to indicate the general… more
- University of Pennsylvania (Philadelphia, PA)
- …control standards for reporting to, and analysis by, the ACC Data and Safety Monitoring Committee ; coordinate DOCM audits with the sites, ensure audits ... and work in coordination with the scientific peer review committee manager to facilitate approval of external sites, write...Director for Quality Control and Compliance to ensure subject safety data from all study sites is… more
- University of Pennsylvania (Philadelphia, PA)
- …quality control standards for reporting to, and analysis by, the ACC Data and Safety Monitoring Committee ; + Work closely with and support the DOCM Audit ... closely with the DOCM Administrative Directors to ensure subject safety data from all study sites is...between the DOCM and the study sites for Medical Monitoring and independent DSMB activities and prepare reports that… more
- Johns Hopkins University (Baltimore, MD)
- …+ Coordinates collection of operations reports, prepares material for Data and Safety Monitoring committee meetings for projects. + Formats reports, ... computer to access e mail, electronic calendars, web pages, Access data bases, Excel data bases, various reference manager programs, and other office support… more
- Bowery Residents Committee (Manhattan, NY)
- …as a program liaison for various client databases, and assisting with data quality assurance processes. Databases include, AWARDS, DHS CARES, and MTA Homeless ... of use + Assist with the preparation of program reports comparing key data from the case management database to internal monthly reports. Program reports may… more
- Bowery Residents Committee (Manhattan, NY)
- …as a program liaison for various client databases, and assisting with data quality assurance processes. Databases include, AWARDS, DHS CARES, and MTA Homeless ... of use + Assist with the preparation of program reports comparing key data from the case management database to internal monthly reports. Program reports may… more
- International Rescue Committee (Sacramento, CA)
- …Job Description From March 2022 - March 2023, the International Rescue Committee launched and implemented a first-of-its-kind service model for the resettlement of ... advanced for the current iteration of the VR&P program, the International Rescue Committee (IRC) aims to meet the ambitious goal of receiving and resettling up… more
- Bowery Residents Committee (Manhattan, NY)
- …reports for senior leadership . + Serv e as a member of the agency-wide safety committee to review incidents and risk mitigation from an insurance perspective , ... including providing real-time reporting of key incidents to committee members and insurance partners. + Prepare agency-wide incident data summaries and conduct… more
- BeiGene (Emeryville, CA)
- … Management Team and Company Safety Committee ) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/ Data and ... Committee + Prepare and support the presentation of safety data at safety governance...Analysis Plans (SAPs), Tables Figures and Listings (TFLs), Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other… more
- International Rescue Committee (Tallahassee, FL)
- …agreement related to the organization. * Assist in performing compliance audits or monitoring to determine whether establish processes and data requirements per ... Arrangement:Open to Remote Job Description BACKGROUND: The International Rescue Committee (IRC) responds to the world's worst humanitarian crises...over 40 countries and 24 US cities to restore safety , dignity and hope, the IRC leads the way… more
