knowledge of clinical trial management systems (CTMS), electronic data capture (EDC), and trial master file (TMF). Experience... for entire projects or processes, contributing to work group objectives. Innovation and Complexity: Address complex problems...
. Support inspection readiness through analytics related to TMF completeness, overdue actions, protocol compliance, training... benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision...
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...
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...
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...
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...
, 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...