- Sumitomo Pharma (Boston, MA)
- …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
- Dana-Farber Cancer Institute (Boston, MA)
- …budgets, resources, and coordinating with cross-functional teams to meet project milestones. + ** Trial Master File ( TMF ) Development and Maintenance:** ... for the day-to-day coordination and management of Cutaneous Oncology clinical trial activities, primarily focusing on multi-center, PI-initiated trials. They ensure … 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
- 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 (Boston, MA)
- …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 (Boston, MA)
- …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