- 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
- Actalent (Durham, NC)
- …ensure the integrity of trial documentation. Responsibilities * Maintain and oversee the Trial Master File ( TMF ) for active medical device studies, ... post market IDE exempt requirements. * Contribute to operational efficiency by aligning TMF processes with trial timelines and deliverables. Essential Skills &… more
- Actalent (Philadelphia, PA)
- …The TMF Specialist serves as the subject matter expert for all aspects of the Trial Master File ( TMF ). This role is responsible for overseeing ... studies, and supporting compliance with regulatory standards. Responsibilities + Act as the TMF expert for all studies and provide guidance on best practices. +… 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
- 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
- Parexel (Juneau, AK)
- …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
- 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 (Atlanta, GA)
- …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
- 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 (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 (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
- 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