- Sumitomo Pharma (Atlanta, GA)
- …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
- ThermoFisher Scientific (Suwanee, GA)
- …responsibilities and tasks:** **Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File ( TMF )** + In charge of ... and EU) + Responsible for ensuring study documentation (including trial master files, study related contracts and...Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master … 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 . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** +… 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
- IQVIA (Marietta, GA)
- …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
- Sumitomo Pharma (Atlanta, GA)
- …and procedures **Key Core Competencies** + Demonstrated understanding of Trial Master File structure and TMF systems + Experienced in problem-solving, ... and Responsibilities** + Conducts periodic quality reviews of study Trial Master Files to ensure quality, completeness...Able to support training and delivery of guidance on TMF standards + Experience in relevant regulatory requirements +… more