- Sumitomo Pharma (St. Paul, MN)
- …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
- Olympus Corporation of the Americas (Center Valley, PA)
- …Act as the Subject Matter Expert and primary point of accountability and reconciliation for the Trial Master File ( TMF ) and the Investigator Site File ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting the… more
- Actalent (South San Francisco, CA)
- …members on study protocol and trial conduct processes + Ensure that the Trial Master File ( TMF ) is set up and maintained appropriately throughout the ... trial and conduct periodic TMF reviews/QCs, as needed + Ensure the clinical trial (s) are inspection ready at all times and participate in Quality Assurance… more
- Dana-Farber Cancer Institute (Boston, MA)
- …budgets, resources, and coordinating with cross-functional teams to meet project milestones. + ** Trial Master File ( TMF ) Development and Maintenance:** ... for the day-to-day coordination and management of Cutaneous Oncology clinical trial activities, primarily focusing on multi-center, PI-initiated trials. They ensure … more
- Regeneron Pharmaceuticals (Armonk, NY)
- …of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File ( TMF ) etc. + Ensures compliance with the ... limited to database lock, reconciliation of vendor contracts, budget, TMF , and study drug accountability + Contributes to clinical...masked investigational product, set up and management of unmasked trial master file , review of… more
- ThermoFisher Scientific (Wilmington, NC)
- …and review (including appendices)** **Collect/review/ File study documents in support of the trial master file ( TMF )** **Collect/review/ File study ... may include but are not limited to PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office),...than one therapeutic area is advantageous.** **Advanced degree(s) (eg, Master or Doctorate) and relevant training or experience (eg,… more
- Takeda Pharmaceuticals (FL)
- …inspection readiness projects. + Support real-time regulatory inspections and audits. + Contribute to Trial Master File ( TMF ) health improvement efforts ... execution processes. + Pilot innovative technologies and automations for Trial Master File oversight **How...Cambridge, MA location. + Must be pursuing a Bachelor's, Masters , or Doctoral degree in a scientific, business, or… more
- ICON Clinical Research (NJ)
- …supports with clinical trial registry postings + Performs scheduled reconciliations of study Trial Master File ( TMF ) with clinical study lead ... supporting global trials (NA, LAM, EU, APAC, India) + Experience working in TMF , CTMS, Sharepoint, + Excels in written and verbal communications + Self-starter, can… more
- ThermoFisher Scientific (Richmond, VA)
- …- Assists clinical study teams as required per WPD/SOP with filing of all documents for the trial master file ( TMF /eTMF) and case report forms (CRF). - ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve… more
- Lilly (Boston, MA)
- …punctual review of invoices. + Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File ( TMF ) by performing periodic QC ... vendors to ensure high-quality execution. + Lead internal clinical trial team meetings, tracking key study metrics (eg, enrollment,...reviews to ensure the TMF is always "inspection ready". + Lead, mentor, and… 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
- Rhythm Pharmaceuticals (Boston, MA)
- …mitigation strategies + Oversee and coordinate with document specialists regarding study files and Trial Master File ( TMF ) quality checks, including ... study activities leveraging internal and CRO resources, expertise and knowledge + Provide trial cost estimates and timelines as part of CDP development + Drive… more
- IQVIA (Overland Park, KS)
- …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 (Overland Park, KS)
- …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
- IQVIA (Overland Park, KS)
- …start-up phase. + Document Management: Ensure site documents are available for filing in the Trial Master File ( TMF ) and verify that the Investigator's ... Management: If applicable, manage site financials according to the clinical trial agreement and retrieve invoices as required by local regulations.… more
- IQVIA (Lenexa, KS)
- …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
- Vitalief (Phoenix, AZ)
- …to ensure alignment with study timelines and quality expectations. + Review and maintain Trial Master File ( TMF ) content for accuracy, timeliness, ... Development, Regulatory, Data Management, Safety, and Quality teams to ensure seamless trial execution. + Support audit and inspection readiness efforts and assist… more
- IQVIA (Tampa, FL)
- …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...Doctorate and 2+ years of Industry experience OR + Master 's and 6+ years of Industry experience OR +… more
- System One (Basking Ridge, NJ)
- …activities, including product destruction, study close-out, and filing documents in the electronic Trial Master File (e- TMF ). Requirements: + Background ... Pay: $30-34/hour Responsibilities: + Monitor and assess temperature data for clinical trial shipments and on-site storage. + Collaborate with Quality to evaluate… more