Clinical Research Manager (CRM) Lead - Oncology/Early Development

Job Description

This role will be key to further develop the country capabilities in clinical research. Under the directionofthecountryorclusterCRD/TA-Headthepersonwillberesponsiblefortheend-to-end performanceofclinicaltrialsin1orseveralTherapeuticAreas(TA),fromfeasibilitytocloseoutin 1 or several countries. The role will be responsible for oversight of the employees working in the TA,withlinemanagementofCRMsandfunctionaloversightsofotherrolesintheirstudies.Atthe discretion of the CRD/TA Head, the role could also be responsible for direct project work and will ensure excellent study performance with strict adherence to local regulations, our company's SOPs and ICH GCP.

Aslinemanagertheroleiscriticaltodevelopkeytalentsintheorganizationtoensureapoolof successorsin critical roles.

TherolewillworkatcountrylevelwithotherlocalstakeholderlikeGMA,GHH,PVandregulatory to ensure alignment and development of the country capabilities and collaborates and works closely with other stakeholders in the TA in GCTO & GCD.
Responsibilitiesinclude,butarenotlimitedto:

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Willlead1orseveralTAofthegrowingportfoliointhecountry.

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Accountableforthesuccessfulexecution,enrollmentandqualityoftheirclinicaltrialportfolio.

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Accountabletoensureperformancemetrics,timelinesandkeymilestonesaremetin compliance with ICH/GCP and country regulations, our company's policies and procedures,qualitystandardsandadverseeventreportingrequirementsinternallyand externally.

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Accountabletodevelopoperationalstrategiesandqualityplansfortheconductofall programs and studies in the TA portfolio.

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CollaborateswithotherTAdirectors,localandregionalstakeholderinGCTOinorderto develop and build territory of principal investigators and sites.

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EnsuresoversightandlinemanagementofClinicalResearchManager(CRM)team.

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Overseetheperformancemanagementandcareerdevelopmentofstaffandeffectively manage performance issues.

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LeadateamindependentlywithsupervisionfromCRD/TAHtohighperformance.

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AccountableforCRMperformancereviews,includingaddressinglowperformancesituations, and taking appropriate actions.

- Ensureskeytalentdevelopmentandretention.

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Collaboratesinternallywiththecross-functionalteamsonlocal,regionalandgloballevel.

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Collaboratesexternallywithinvestigators,regulatorsandvendors

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Supportsstrategicinitiatives acrosscountry,GlobalClinicalDevelopmentGCDand GCTO.

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Supportslocalstrategydevelopmentconsistentwithlong-termcorporateneedsin conjunction with CRD.

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Togetherwithdirectreportscontributessignificantlytoeffectiveconductofclinicalstudies and to develop the pipeline, while maintaining regulatory requirements and compliance.

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MainPointofContact(POC)forassignedprotocolsandlinkbetweenCountry Operations and Clinical Trial Team (CTT).

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Responsibleforprojectmanagementoftheassignedstudies:pro-activelyplans,drives andtracksexecutionandperformanceofdeliverables/timelines/resultstomeetcountry commitments from feasibility and site selection, recruitment, execution and close out.

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Reviews Monitoring Visits Reports and escalates performance issues and training needs toCRA-Managerand/orfunctionalvendorandinternalmanagementasneeded. Performs Quality control visits as required.

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Leadslocalstudyteamstohighperformance:trainsintheprotocolotherlocalroles, closelycollaborateswithandsupportsCRAsasprotocolexpertandcoordinatesactivities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).

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Responsibleforcreatingandexecutingalocalriskmanagementplanforassignedstudies.

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EnsurescompliancewithCTMS,eTMFandotherkeysystemsinassignedstudies.

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EscalatesasneededdifferentchallengesandissuestoTA-Head/CRD/CCQMand or CTT (as appropriate).

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Identifiesandsharesbestpracticesacrossclinicaltrials,countries,clusters.

- Mayactasa mentor.

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Responsibleforcollaborationwithfunctionaloutsourcingvendors,investigators, other external partners in assigned studies.

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CountryPOCforprogrammaticallyoutsourcedtrialsforassigne