- 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
- 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
- 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
- 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
- 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 (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 (Boston, MA)
- …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 (Overland Park, KS)
- …phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) and verify that the Investigator's ... 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
- Dignity Health (Phoenix, AZ)
- …with internal and external project stakeholders + Manage study related regulatory documents and ensure the Trial Master File ( TMF ) is up to date and ... manage scope, schedule/timelines, budget, quality and resources of the assigned trial (s). Study management will also include outside clinical site management, vendor… 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
- 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
- BeOne Medicines (Emeryville, CA)
- …and site activation plans + Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ) are created, ... training records are well documented and filed + Ensures Trial Master File for study...QC'd on a regular basis as per the study TMF QC plan + Collaborates closely with Global Clinical… more