Senior Clinical Trials Leader job – Clinical Dynamix, Inc. – Princeton, NJ

Senior Clinical Trials Leader

Clinical Dynamix, Inc.

Princeton, NJ

Senior Clinical Trials LeaderSummery: ClinicalTrialLeader(CTL)isaccountableforplanning,executingandtosupportreportingon globalphaseI-IVclinicaltrialsfromoperationalplanningthroughtrialclose-out,incompliancewith company processes, GCPIICHandregulatoryrequirementsunderthesupervisionofGroup ClinicalOperationsLeader. Major Accountabilities: Operationalizeprotocol. Managetrialallocationandcoordination/managementofactivitiesleadingtoinitiationofsites inup to 4 different countries. Prepare,ImplementandManageVendors inU.S.

and other Countries. Manageandcoordinatetestarticleandnon-drugsuppliesacrossregions. Manageoveralltrialconducttotrialclose outincoordinationwithlinefunctionsandCRO. Facilitatetrialcloseoutactivities.

Key Performance Indicators: Efficient,quality-driven,timelyexecutionofglobalclinicaltrials(i.e.,bestsitesselectedforagiventrial,optimizationofstudystartup,100%oftargetenrolmentatlast patientfirsttreatment)incompliancewith internationalandlocalregulationsand companyinternalstandards Datacleaning processissuccessfullyaccomplishedwithintherequiredtimelines acrossthetrialwith100%cleandataandnodatabaseunlocks Timelysubmissionanddeliveryofhighqualityclinicaltrialdocumentsresponsible fortoachievecriticalmilestones Proactiveoperationalplanningwitheffectivecontingencyandriskmitigationplans CosteffectivemanagementofbudgetandresourceswithlimitedunforeseencostoverrunsJobDimension: Responsibilityforglobaltrialbudgetpreparationand trackingof trialcosts.Timely submissionofglobal clinicaltrialresults, supportingproductapprovalandcommercialization;keytoensurethatcompanyledstudiesareexecutedaccordingtointernaland external standardsandregulations,andthat companyreputationasacredible,ethicalandpreferredpartneris maintained/enhancedwithawillingnessfrom investigatorstoworkwithcompany.Education Background: Bachelor’sdegreeorequivalentqualificationinlifesciencehealthcare,Masterdegreeispreferred.Experience: Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process. Demonstrated ability to influence without authority. Project Management experience preferred. At least two years operational experience in planning, executing, reporting clinical trials.

Excellent negotiation and conflict resolution skills. Ability to collaborate across partner functions in a matrix environment. Consistent results in clinical operations. Ability to work in and lead global cross-functional teams.

Strong interpersonal skills. Ability to work under pressure, resolve issues with supervision and understand when to escalate. Demonstrated ability to effectively manage trial.

Clinical Dynamix, Inc., established in 1999, specializes in all levels of Clinical Research and Medical Affairs, both permanent and…

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