- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File ( TMF ) according to applicable ... documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), Data Structure Specifications (eDTS) to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operating models.Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File ( TMF ) according to applicable ... documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of study programming deliverables, maintain all required study programming documentation required for Trial Master File ( TMF )- Maintain institutional ... accommodation. Education Qualifications (from an accredited college or university)- Master 's Degree Biostatistics or similar degree required- PhD Biostatistics or… more
- Merck (West Point, PA)
- …and timely reporting (eg, milestone dates in the Clinical Trial Management System (CTMS), Trial Master File ( TMF ), Clinical Study Reports (CSR)) + ... accuracy across multiple business systems and tools (ESTAR-Early Stage Trial Tracking & Reporting, TMF , CTMS, REDS)...Life Sciences and minimum 4 years related experience, OR Master 's degree in Life Sciences and minimum 3 years… more
- University of Pennsylvania (Philadelphia, PA)
- …activities; Includes coordinating/hosting the site initiation visit (SIV) + Establish/maintain the Sponsor Trial Master File ( TMF ) + DSMB ... programs and resources, and much more. Posted Job Title Sr. Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job Profile Title Manager Research… more
- Novo Nordisk (Lexington, MA)
- …study documents, such as consent forms, study manuals, subject recruitment materials + Oversee the Trial Master File ( TMF ) and assist with periodic audit ... role will be responsible for all aspects of clinical trial management aimed at treating a rare liver-targeted disease....of the TMF + Drive critical clinical trial activities including trial site activations, recruitment,… more
- Pfizer (Cambridge, MA)
- …document sharing platforms, overseeing the transfer of study documents from Pfizer to the CRO/ Vendor Trial Master File ( TMF ) and final TMF transfer ... for the transfer of Pfizer authored essential documents to the CRO/Vendor Trial Master File . + Attends investigator meetings. + Ensure timely close-out… more
- Abbott (Alameda, CA)
- …the preparation of all applicable documents required for the conduct of the study (such as Trial Master File ( TMF ), Clinical Protocols and Reports). + ... evaluation, selection, and training of new study investigators. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review of… more
- Abbott (Alameda, CA)
- …the preparation of all applicable documents required for the conduct of the study (such as Trial Master File ( TMF ), Clinical Protocols and Reports). + ... evaluation, selection, and training of new study investigators. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review of… more
- WuXi AppTec (Austin, TX)
- …review, and distribute regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File ( TMF ) Plan and conducts ... documents. + Supports requests resulting from internal and external TMF audits. + Serves as primary site contact for...as required, including but not limited to review of trial and site study files. + Assists with communication… more
- Takeda Pharmaceuticals (Columbus, OH)
- …avoid and resolve risks. + Confirm archival and inspection readiness of all Clinical Technology Trial Master File ( TMF ) documents + Participate in ... well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds. The EDC Engineer maintains and serves as an expert for… more
- United Therapeutics (Durham, NC)
- …preparation of study-related documents, tools, and templates. + Contribute to timely and quality Trial Master File ( TMF ) management and completeness. + ... **How you'll contribute** The Clinical Monitoring/Records Management Summer Intern will review Trial Master File documentation created/collected for the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …models. + Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File ( TMF ) according to applicable ... documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to… 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 ... Research Associate I you will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to… more
- IQVIA (Lincoln, NE)
- …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 (San Diego, 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)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of study programming deliverables, maintain all required study programming documentation required for Trial Master File ( TMF ) - Maintain institutional ... accommodation. **Education Qualifications (from an accredited college or university)** - Master 's Degree Biostatistics or similar degree required - PhD Biostatistics… more
- Danaher Corporation (Chaska, MN)
- …development of study essential document templates (eg, study guides, study tools/worksheets) and ensure Trial Master File ( TMF ), Sponsor Site Files ... years' experience in vitro diagnostics (IVD), Medical Device, or Healthcare clinical field, Master 's degree in field with 3+ years, or Doctoral degree with 0-2+… more
- Gilead Sciences, Inc. (Seattle, WA)
- …. QUALIFICATIONS: + BA or BS and 12+ years' experience in compliance and trial master file in pharmaceutical/biotechnology industry. + Excellent working ... (FSP) to ensure timely and quality delivery of the TMF . This role is a member of the Clinical...and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program. The ideal candidate… more
