- Sumitomo Pharma (Sacramento, CA)
- …information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File ( TMF ) Specialist will be ... for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits...overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF… more
- Parexel (Sacramento, CA)
- …documentation, updates and tracking within required timeframes, including but not limited to Trial Master File ( TMF ) documentation, site reports, ... with the set-up, running and close-out of sites in a clinical trial . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** +… more
- Parexel (Sacramento, CA)
- …documentation, updates and tracking within required timeframes, including but not limited to Trial Master File ( TMF ) documentation, site reports, ... with the set-up, running and close-out of sites in a clinical trial . **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical… more
- Abbott (Alameda, CA)
- …planning, designing case report forms (CRFs), and training of study sites. + Maintain and audit Trial Master File ( TMF ) and upload to eTMF to ensure ... Opportunity** The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to… more
- IQVIA (Carlsbad, CA)
- …phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) verify that the Investigator's Site ... be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications *… more
- IQVIA (San Francisco, CA)
- …start-up phase. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) and verify that the ... be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Education:… more
- IQVIA (Carlsbad, CA)
- …Support start-up phases as required. Documentation: Ensure all site documents are filed in the Trial Master File ( TMF ) and Investigator's Site File ... Associate! You'll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor… more
- Stryker (Fremont, CA)
- …+ Upload acquisitions into the Clinical Trial Management System (CTMS) and maintain Trial Master File ( TMF ) in inspection-ready state. + Communicate ... with assigned sites to collect and review essential documents; perform quality control reviews and resolve issues. + Support development and maintenance of study documents and templates to ensure data integrity and compliance with federal regulations and… more
- IQVIA (Sacramento, CA)
- …of data queries. + Ensure that essential documents are collected and maintained in both the Trial Master File ( TMF ) and the Investigator Site File ... (ISF) in accordance with regulatory standards. + Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence. + Work closely with cross-functional project teams to support study execution and ensure… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file ( TMF ). + Maintains compliance with ... ERP system. Has good understanding and working knowledge in master data management. + Data and analytics: oversees the...supply chain. **Basic Qualifications:** + Doctorate degree OR + Master 's and 4+ years of Industry experience OR +… more
- BeOne Medicines (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 ... clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for...basis as per the study TMF QC plan + Provides input to Global Clinical… more