for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). Serves as subject matter... expert for Clinical information systems, including a Clinical Trial Management System (CTMS), electronic TMF (eTMF) end-users...
of contentment, financial rewards and career growth, which is why we have such stability in the group! What you'll be doing... checklist and data verification Reviews PDF packages and supports TMF readiness Quality, Risk & Compliance Improves...
systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging;managing meetings (creating agendas... in multiple time zones across the globe;using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO...
, working closely with other members of the clinical research group within clinical development (medical lead, medical monitor... protocol deviations are appropriately managed and reconciled;leads protocol deviation trends review Ensures TMF compliance...
with other members of the clinical research group within clinical development (medical lead, medical monitor, statistician, medical... protocol deviation trends review Ensures TMF compliance for clinical documents Provides clinical input and review of the...
systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging;managing meetings (creating agendas... in multiple time zones across the globe;using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO...
for all phases of clinical trials and programs as part of the research and development group. This role will proactively participate... reconciliation, Vendor Oversight, TMF plans, and data audits. Following CDISC conventions, oversees or performs eCRF design...
to the development of junior clinical team members. Assist in ensuring audit readiness, by ensuring the eTMF/TMF are up... tools as needed (via Clinical Trial Management system) Liaise with the Safety group in the management of serious adverse...
generated. Add and maintain appropriate accountability records in the TMF. Review master batch/executed production records.... Lead a regulatory intelligence working group and stay updated on regulatory trends and changes, proactively adapting...
, and other study level documents Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial..., and service providers In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant...