quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). May serve as subject matter expert... for electronic TMF (eTMF) end-users, and facilitates responses to audits/inspections. Collaborates closely with the Clinical...
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...
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...
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...
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...
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...