Clinical Research Medical Advisor

**Primary Location**: Mexico, Remote**Job ID** R **Category** Medical Sciences**ABOUT THIS ROLE**:**Job Summary**- Accountableforallcountryclinical/medicalaspectsassociatedwithDevelopmentandprioritizedRe-search programs/trialsbyprovidingclinicalstrategicandtacticalleadershipastheCountryClinicalDevelopment representative. May work across several countries.- Gathers,informs,andactsonclinical/medical/scientificinsightsforclinicaltrialconceptsheets/protocols, InformedConsentForms(ICFs)andotherrelevantclinicaldocumentstooptimizeclinicaltrialimplementation.- Drivestheidentificationandinvolvementofqualifiedinvestigatorswithgreatestrecruitmentpotential,identifies clinicalrecruitmenthurdlesanddrivesclinicalrecruitmentactivitiestoovercomethesehurdles.- Accountableforadherencetosafetystandardsandclinicaldataqualityinthecountrybyprovidinggeneral clinical/medicalsupportfortrialrelatedsafetyfindings.- Inclosecollaborationwithothercountryfunctions(e.g.,clinicaltrialoperations,MedicalAffairsandPatient Engagement)activelycontributestosuccessfulallocation,fastclinicaltrialstart-up,timelyrecruitment,early identificationofpotentialdelays,anddevelopmentandimplementationofmitigationplans.**Responsibilities**:Major Accountabilities**From**Strategy**to**Functional**Excellence**ProvidesClinicalDevelopmentandindicationexpertisespecifictoCountry/Cluster,andtogetherwiththeclinicaltrial operationsteam,drivestheexecutionofclinicaltrialswithhighqualityandwithinplannedtime-lines:- Validatesstudydesigns,isaccountablefor,andmakesthefinaldecisionontheclinical/medicaltrialand program feasibilityofimplementinga clinicaltrialprotocolbasedon medical/clinicalpracticeandanalysis ofthe competitive environment in the country.- Activelycontributestoscientific/clinical/medicalaspectsofthestart-upphasetoensurefast clinicaltrialsite start-up.- Providesclinical/medicalexpertisetoclinicaltrialoperationsteammembersand clinicaltrialsites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.- Decidesonsite/Country-specificscientific/clinical/medicalcontentoftheInformedConsentForm(ICF)as needed and ensures appropriateness of patient suitable language.- Providesscientific/clinical/medicalexpertiseduringinteractionswithCountry/ClusterexternalExperts(e.g., RegulatoryAuthorities,MedicalExperts,AdvisoryBoards,PatientAdvocacyGroups,etc.).- Developsclinical/medicaltrialplanstakingthebroaderecosystemintoaccountforassignedpro-grams/trialsto ensure successful trial implementation, which includes:- Pro-activelyidentifyingearlyonclinicalchallengestorecruitmentorclinicaldataqualityanddrives development of clinical/medical mitigation plans.- Buildingdiseaseareaexpertise,especiallyfornew/rareindications- Providesrobustindication,compound,andprotocoltraining:- Totheclinicaloperationsteaminthecountry,especiallytotheClinicalResearchAssociates,and other country line functions as needed.- Externallyasneeded intheCountry/Clusterat Investigator’sMeetingsorscientificvenuestosupport recruitment and trial awareness.- Leveragesinnovationinclinicaltrialplanninganddecidesonclinical/medicalrecruitmentstrategyand implementationbased uponphysician interviews,analysis ofcompetitive trials,and patient engagement.- Asthescientific/clinical/medicalexpert,supportsandpartnerswithinternalStakeholders(e.g.,ClinicalTrial Team,RegulatoryAffairs,MedicalInformation,MedicalAffairs,Marketing, PatientAccess, HECOR, clinicaltrial operations,etc.),andinternaldecisionboardsasneededregardingclinicaltrials.- Gathers,informs,andactsoninsightsfromclinicaltrialInvestigators/sitestaff,MedicalExperts,patients,and payers,withinternalStakeholdersattheCountry/Clusterlevelwiththegoaltooptimizeclinicaltrial implementation.- Supports planning, implementation, and follow-up ofscientific/clinical/medical components ofRegulatory Authority inspections and internal audits.- Reviews and resolves Country trial-related scientific/clinical/medical issues/questions.If necessary, initiates the discussion with the Global Clinical Development team.- Accountableforadherencetosafetystandards,clinicaldataqualityfortheCountry/Clusterandpro-vides general scientific/clinical/medical support for safety issues:- Providesclinical/medicalexpertise tosupportpharmacovigilance activities.- Maybeinvolvedinreviewingtheclinical/medicalaspectsofclinicaltrialSeriousAdverseEvents(SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.- Follows-up withtheInvestigatorforadditionalclinical/medicalinformationorclarifications forAEsand SAEsandprovidesclinical/medicalexpertiseforsafetyamendments,InvestigatorNotifications(INs), Urgent Safety Measures (USM), etc. as needed.- SupportstheGlobalClinicalDevelopmentteamasneededtoaddress/clarifyclinical/medicalProtocol Deviations through follow-up with clinical trial sites.- MaysupportinnovativestudydesignsbyidentifyingandconductingqualityassessmentsofC