Senior Associate Manager Disclosure Global Clinical Trial Transparency

3 weeks ago


Hatfield, Hertfordshire, United Kingdom CK Group Full time

pbJobTitle:/bSeniorAssociateManagerDisclosureGlobalClinicalTrialTransparency/ppbJobSummary:/b/ppWeareseekingahighlyskilledSeniorAssociateManagerDisclosureGlobalClinicalTrialTransparencytojoinourteamatCKGroup.Asakeymemberofourteam,youwillberesponsibleforensuringcompliancewithdisclosureprocessesanddemonstratingsuccessinsupportingtheactivitiesofteammembersassignedtodisclosureoperations./ppbKeyResponsibilities:/b/pulliPerforming/coordinatingallactivitiestomeetdisclosureobligationsfortheregistration,maintenance,andresultspostingonclinicaltrials.gov,clinicaltrialsregistry.eu,andanyotherapplicablerepositories./liliWorkingcloselywithinternalandexternalteamstofulfillandensurethattheyunderstandtransparencyanddisclosureobligations./liliMaintainingawarenessofexistingandemergingguidanceondisclosureprocesses,updatinginternalprocesses,andperformingtrainingwhereneeded./liliSupportingandcontributingtotheimplementationandupgradeofthedisclosuresystem,frominitiationtodeployment./liliContributingtotheregularassessmentofdisclosureactivitiesforrisk,andthatanyrisksidentifiedaretracked,managed,andpotentialmitigationandimplementationstrategiesaredeveloped./liliPreparingtrainingmaterialsanddeliveringtrainingonend-to-enddisclosureoperationsprocess,importantprocesschanges,andotherassociatedtopicstoallstakeholdersinvolved./li/ulpbRequirements:/b/pulliEducatedtodegreeleveloraboveinlifesciencesorarelatedfield./liliStrongworkingknowledgeofclinicaldisclosurerulessuchasFDAAA801,EudraCT,PhRMA/EFPIAprinciplesforresponsibledatasharing,etc./liliProvenanddemonstratedexperiencewithclinicaltrialtransparencyordisclosurewithinthepharmaceuticalindustryasanSMEwithintheclinicaltrialdisclosurearea./liliStrongworkingknowledgeofstudyregistrationandresultsdisclosureonclinicaltrials.gov./liliUnderstandingofclinicaldevelopmentwithinthepharmaceuticalindustry./liliExcellentcommunicationandrelationshipbuildingskillswiththeabilitytodriveprojectswithconflictingprioritiesinamatrixteamenvironment./li/ulpbApply:/bItisessentialthatapplicantsholdentitlementtoworkintheUK.Pleasequotejobreference106434inallcorrespondence.



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