Clinical Research Medical Advisor

**Primary Location**: Mexico, Remote

**Job ID** R0000034950

**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