- University of Pennsylvania (Philadelphia, PA)
- …Includes coordinating/hosting the site initiation visit (SIV) + Establish/maintain the Sponsor Trial Master File (TMF) + DSMB Coordination/Management- ... development. + Identifying/implementing new technology/systems required to enhance clinical research operations . In this role, the Sr Clinical Trial Project… more
- ThermoFisher Scientific (Suwanee, GA)
- …in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems + Effective oral and written ... portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy...on - now and in the future. **Our Clinical Operations team within the PPD clinical research business of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …documents, with timely, complete and compliant archiving of all relevant documents for the electronic Trial Master File (eTMF) and Clinical Trial Report ... set up and manage external suppliers that meet requirements of local/regional trial operations . * Set up, manage and review operating unit (OPU) trial… more
- AbbVie (North Chicago, IL)
- …storage, and/or destruction per requirements + Deposit biomarker related documents to the Trial Master File , ensuring that documentation standards are ... a global mindset and cross-functional collaboration. Responsibilities: + Manage the biomarker operations and logistics to align with clinical trial schedule +… more
- TE Connectivity (Carlsbad, CA)
- …invoicing, and work with finance teams to reconcile expenses related to the CTMS. + ** Trial Master File (TMF) Management** + Oversee eTMF setup, ongoing ... process. + **Team Management** + Lead, mentor, develop, and manage Clinical Operations Teams, including Clinical Trial Assistants and Clinical Operations … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …/ debugging, deployment, and manages the ongoing operational production operations of analytic dashboards, databases, applications, and integrations supporting ... scheduling / orchestration tools (Tidal Enterprise Schedule or equivalent), enterprise Managed File Transfer tool (Cleo Harmony or equivalent). Must be able to… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical ... masked investigational product, set up and management of unmasked trial master file , review of...Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical ... masked investigational product, set up and management of unmasked trial master file , review of...Word, Excel, IVRS/IWRS, EDC + Experience in global clinical trial operations including experience developing protocols and… more
- Mount Sinai Health System (New York, NY)
- …in managing and coordinating regulatory projects. This role includes maintaining the electronic Trial Master File (eTMF) and ensuring compliance with ... management of the electronic systems most important to MCTO operations . The Regulatory Project Coordinator will be responsible for...submissions and correspondence. + Maintain and manage the electronic Trial Master File (eTMF) to… more
- TE Connectivity (Carlsbad, CA)
- …knowledge of sponsor site clinical trials and/or CRO industry experience. + Experience with trial master file management. + Meticulous attention to detail ... Clinical Operations Specialist **At TE, you will unleash your...+ Support the coordination of the transfer of study-specific trial master files from the CRO. +… more
- AbbVie (South San Francisco, CA)
- …management best practices and ethical guidelines. Ensure appropriate documents are added to the Trial Master File . + Provide leadership and mentoring for ... mindset, team building and cross-functional collaboration. Responsibilities: + Manage biomarker operations and logistics to support the clinical trial schedule,… more
- Mount Sinai Health System (New York, NY)
- …reporting, and any migration of data to future systems. + Manages the electronic trial master file managements system. + Manages the electronic list-serve ... agreed upon with the Senior Director of the Clinical Trial Operations and the Principal Investigator of...**Qualifications** + Bachelors Degree in Administration, or related field Masters preferred + 7 years experience in a research… more
- University of Colorado (Aurora, CO)
- …**Job Summary:** **Key Responsibilities:** + Assist with and oversee the day-to-day operations of clinical trials and studies + Obtain study subject's medical ... and confirms eligibility of subject to participate in clinical trial + Perform informed consent process or ensures that...or CRC II, all the above and:_** + Independently master study materials, including but not limited to protocols,… more
- University of Colorado (Aurora, CO)
- …**_Entry Level or CRC I:_** + Assist with and oversee the day-to-day operations of clinical trials and studies + Obtain study subject's medical history and ... and confirms eligibility of subject to participate in clinical trial + Perform informed consent process or ensures that...or CRC II, all the above and:_** + Independently master study materials, including but not limited to protocols,… more
- AbbVie (Waltham, MA)
- …management best practices and ethical guidelines. Ensure appropriate documents are added to the Trial Master File . Qualifications Qualifications: + BS, MS or ... mindset, team building and cross-functional collaboration. Responsibilities: Manage biomarker operations and logistics to support the clinical trial … more
- Regeneron Pharmaceuticals (Armonk, NY)
- …& Inventory Planning + IP Shipments + IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF) + Ancillary Supply & Inventory ... The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug...knowledge of the clinical drug development process and clinical trial methodology including the inner-workings of cross-functional partners +… more
- Abbott (Alameda, CA)
- …meetings, evaluation, selection, and training of new study investigators. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform ... completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively and effectively communicate...required for the conduct of the study (such as Trial Master File (TMF), Clinical… more
- US Army Reserve Command (Hays, KS)
- …the Army Reserve, visit http://www.goarmy.com/reserve/jobs.html Responsibilities Serve as a Staff Operations and Training Specialist in an Army Reserve Brigade or ... to subordinate units to ensure data contained in the unit mobilization file is complete and accurate. Requirements Conditions of Employment Qualifications Who May… more
- AbbVie (North Chicago, IL)
- …storage, and/or destruction per requirements + Deposit biomarker related documents to the Trial Master File , ensuring that documentation standards are ... a global mindset and cross-functional collaboration. RESPONSIBILITIES: + Manage the biomarker operations and logistics to align with clinical trial schedule +… more
- BeiGene (San Mateo, CA)
- …responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular ... in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master 's degree in a scientific or healthcare discipline and 6+ years of… more