- Sumitomo Pharma (Trenton, NJ)
- …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
- Regeneron Pharmaceuticals (Warren, NJ)
- …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
- Parexel (Trenton, NJ)
- …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
- IQVIA (New York, NY)
- …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
- Taiho Oncology (Princeton, NJ)
- … trial completion. + Overall responsible for the Trial Master File , including review of the TMF plan, related metrics, and ongoing quality review of ... or multiple global trials by managing all aspects of trial deliverables, including development of timelines, budget, recruitment and...the TMF . Oversee TMF related CRO and internal… more
- Taiho Oncology (Princeton, NJ)
- …ensure consistency across studies and alignment with internal TMF procedures. + Monitors Trial Master File related KPIs and performs quality review of ... updating of study trackers and systems and overseeing study documentation and Trial Master File . The SA supports the Clinical Operations department with… more