- 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 ) 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
- IQVIA (Lenexa, KS)
- …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
- 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
- IQVIA (Tampa, FL)
- …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
- General Dynamics Information Technology (Fort Detrick, MD)
- …to leadership and sponsor's representative as necessary + Add and maintain appropriate records in the Trial Master File ( TMF ) + Review master batch ... Manufacturing Practices (GMPs); Review batch production records, which are the executed master batch production records, and document that the records are adequate… more