- 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
- ThermoFisher Scientific (Greenville, NC)
- …responsibilities and tasks:** **Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File ( TMF )** + In charge of ... and EU) + Responsible for ensuring study documentation (including trial master files, study related contracts and...Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master … 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
- IQVIA (Parsippany, NJ)
- …and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (eg, Trial Master File ( TMF )) that track site compliance ... * Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. * Assist with the tracking and… more
- ICON Clinical Research (Blue Bell, PA)
- …site activation, mitigation and action planning. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up ... if assigned on the same studies. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up and perform a… 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 (Austin, TX)
- …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
- ICON Clinical Research (Basking Ridge, 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
- Mount Sinai Health System (New York, NY)
- …event documentation, safety reporting, and correspondence with IRBs and sponsors. + Maintain the Trial Master File ( TMF ) and site investigator files ... **Job Description** The **Clinical Trial Manager** provides leadership and oversight for the planning, conduct, and management of clinical trials within the Center… more
- ICON Clinical Research (NC)
- …and escalate issues as soon as identified. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up and ... (SIS) and Informed Consent Forms (ICF): + Prepare, review and approve Global Master ICF templates for Sponsors. + Prepare, review and approve Country Master… more