Clinical Scientist at WIRB-Copernicus Group in Madison, Wisconsin

Job Description:

JOBSUMMARY:TheClinicalScientistsupportsassignedprojectsbyinteractingandcommunicatingwithinvestigativesites,studysponsors,andinternalstakeholderstoensurequalityandtimelydeliveryofallclinicalserviceofferings.TheClinicalScientistrepresentsMA-PPscientificexpertiseatallexternalmeetings.The Clinical Scientist co-leads allassignedprojectswithProjectManagementandcollaboratescross-
departmentallytoensurethesuccessoftheproject.

EDUCATIONREQUIREMENTS:
*Graduate degree inalifesciencedisciplineorotherfieldrelevanttotheMedAvante-ProPhase
businessfocusisrequired.

QUALIFICATIONS/EXPERIENCE:
Five years ofexperienceintheclinicalresearchindustryrequired;experienceworkingforabiopharmaceuticalsponsororaclinicalresearchorganizationpreferred
*Minimum3yearsofexperienceasaclinicalscientist,clinicaltrialscienceleadorsimilarrolewith
client-facingscientificresponsibilities
*Minimum4yearsofexperiencewiththeadministrationofratingscaleswithpracticalknowledge
ofstudyendpointsaspartofsponsoredclinicalresearchisrequired
*Abilitytofunctioneffectivelyinafast-pacedenvironmentandmanage multiple projects
simultaneously
*Abilitytoleadthroughinfluencingandnegotiating;demonstratedleadershipskillsandabilityto
integrateinateam,motivateothersandcommunicateclearlyandeffectively
*Strongproblemsolving/decisionmakingskills,demonstratedbyabilityforindependentcritical
thinking,solutiongenerationandengagementinactivescientificexchange
*Solidunderstandingofbasicandintermediateresearchmethodsandstatistics
*Strongcommunicationandnegotiationskillsacrossaudienceswithademonstratedabilitytoassess
complexsituationsanddeviseimpact-generatingsolutionsbasedonincompletedata.
*Demonstratedabilitytopresentinfrontoflargeaudiencesfromvariedbackgroundsrequiringthe
abilitytotailorthediscussiontomeettheirneeds.
*FluentinEnglish;bi-lingualormulti-lingualskillsarepreferred.
*StrongunderstandingofGoodClinicalPractice(GCP)

ESSENTIALDUTIES/RESPONSIBILITIES:
*Externalfacingclinicalrepresentativeresponsiblefortheindependentclinicalmanagementof
internationalclinicaltrials
*Ownscientificresponsibilityandco-leadeachassignedproject,alongwithaccountabilityfor
ensuringthatthescientificintegrityismaintainedandalnecessaryanalysesandremediations
areconductedandeffectivelycommunicated
*Activelyparticipateininternal andexternal projectmeetings (e.g.,weeklyexternal clientcall,
Investigators'Meetings)
*Review,monitor,andproactivelyaddressissuesregardingstudylevelmetrics;presentstudy
dashboardstosponsorsbyreviewingdata,anyoutliersorareasofconcern,aswellasanyactions
takentoaddresstheseconcerns
*Resolveclinicalqualityortrainingrelatedissues
*Responsibleforthecalibrationofclinicalteam,conductratertrainingevents,andremediationsas
specifiedinthestudy-specifictrainingplans
*Providescientificsupporttoexternalandinternalstakeholders,leveragingstrongcommunication
andnegotiationskillsandstrategies
*RespondtoandresolveexternalinquiriesregardingMedAvante-ProPhasescoringorfeedback
*Communicatewithallinternalstakeholdersandcoordinateresourcestomeetprojectobjectives
*Assistwithortakeresponsibilityforthedevelopmentofprojectdeliverables(e.g.,scaleverification,
electronicformdevelopment,trainingmaterialsforin-personoronlinetraining,etc.)
*WorkwithBusinessDevelopmenttoreviewpotentialstudies,RFPs,asneeded
*Developandnourishpeer-to-peerrelationshipswithexternalconsultants,keyopinionleaders,and
Clinicians,bothregionallyandinresearchareasofinterest
*Activelyparticipateinresearchandpublicationseffortsandreportresearchresultsexternally
throughpeer-reviewedjournals,conferences,orotherappropriatevenues
*Identifytheneedforandcontributetothedevelopmentofdepartmentalandcross-disciplinary
workinstructions,processguidelines andstandardoperatingprocedurestoensureallprocesses
andproceduresmeetSOP/GCPrequirements
*Otherduties asassignedbysupervisor.Thesemay,onoccasion,beunrelatedtotheposition
describedhere.
*ProficientknowledgeofMSOffice,specifically Word,Excel,PowerPointandtheabilitytoproduce
detailedreportsandpresentationsusingthesetools.
*Attendanceandpunctualityareessentialfunctionsoftheposition.

SUPERVISORYRESPONSIBILITIES:Thepositionmayrequiretheindividualtoberesponsibleforthe
management,direction,coordination,performance,andevaluationofanassignedteamandstaff.
Responsibilitiesmayincludetrainingemployees;planning,assigning,anddirectingwork;appraising
performance;rewardinganddiscipliningemployees;addressingcomplaintsandresolvingproblems.

TRAVELREQUIREMENTS:Thisrolemayrequireup20%travelwhichmaybedomesticorinternational,
including overnightandweekendstays,consistentwithprojectneedsandofficelocation.