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:

• Willlead1orseveralTAofthegrowingportfoliointhecountry.

• Accountableforthesuccessfulexecution,enrollmentandqualityoftheirclinicaltrialportfolio.

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

• Accountabletodevelopoperationalstrategiesandqualityplansfortheconductofall programs and studies in the TA portfolio.

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

• EnsuresoversightandlinemanagementofClinicalResearchManager(CRM)team.

• Overseetheperformancemanagementandcareerdevelopmentofstaffandeffectively manage performance issues.

• LeadateamindependentlywithsupervisionfromCRD/TAHtohighperformance.

• AccountableforCRMperformancereviews,includingaddressinglowperformancesituations, and taking appropriate actions.

• Ensureskeytalentdevelopmentandretention.

• Collaboratesinternallywiththecross-functionalteamsonlocal,regionalandgloballevel.

• Collaboratesexternallywithinvestigators,regulatorsandvendors

• Supportsstrategicinitiatives acrosscountry,GlobalClinicalDevelopmentGCDandGCTO.

• Supportslocalstrategydevelopmentconsistentwithlong-termcorporateneedsin conjunction with CRD.

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

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

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

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

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

• Responsibleforcreatingandexecutingalocalriskmanagementplanforassignedstudies.

• EnsurescompliancewithCTMS,eTMFandotherkeysystemsinassignedstudies.

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

• Identifiesandsharesbestpracticesacrossclinicaltrials,countries,clusters.

• Mayactasamentor.

• Responsibleforcollaborationwithfunctionaloutsourcingvendors,investigators, other external partners in assigned studies.

• CountryPOCforprogrammaticallyoutsourcedtrialsforassignedprotocols.

• Asacustomer-facingrole,thispositionwillbuildbusinessrelationshipsandrepresent our company with investigators and medical centers.

• Serveslocalbusinessneedsasapplicableinhis/hercountry(ifdelegatedcansign contracts and manage budgets).

• Supports local and regional strategy development consistent with long-term corporateneedsinconjunctionwithCRD,TA-HeadandRegionalOperations.

Extent of Travel: Up to 30% of working time

Skills:

• Expertiseinprojectandsitemanagement.Thepositionrequiresdemonstratedsuccessful implementation of project management skills at program and site level.

• Strongorganizationalskillswithdemonstratedsuccessrequired.

• Requiresabilitytomakedecisionsindependentlyandoverseeimportantactivitiesrelevantto clinical research activities according to predetermined global policies and commitments.

• RequiresacompleteunderstandingofICHGCPandglobal/regional/localregulatory environment.

• Strongscientificandclinicalresearchknowledgeisrequired.Includingextensiveknowledgeof regional and/or country clinical trial landscape.

• Deepunderstandingofour research & development divisionorganizationalstructureandcross-functionalrolesandresponsibilities of its members.

• Strongunderstandingofclinicaltrialplanning,managementandmetricsisessentialaswellas theability to focus onmultiple deliverables and execute complex protocols simultaneously.

• ExperiencefunctioningasakeylinkbetweenCountryOperationsandClinicalTrialTeams.

• Communicateseffectivelyandfostersacollaborativespiritinaremote/virtualenvironment and across countries, cultures and functions.

• Ability,experience,andskillstoproactivelymanageresourceallocation,processes(and controls), productivity, quality and project and/or program delivery.

• OverseeTAstrategyalignmentandconsolidaterelevantinformation,withinspecificindications, escalating to the TA-H / CRD accordingly.

• ProficiencyinwrittenandspokenEnglishandlocallanguage.Theincumbentmustbe competent and effective in written and verbal communication.

• Strategicthinking.

• Abilitytoworkefficientlyinaremoteandvirtualenvironment.

• Thepositionrequiresprovenstrongprojectmanagementskillsand/orprojectmanagement certification or relevant training program/close mentoring.

• Highemotionalintelligence.

• Abilitytofocusonmultipledeliverablesandprotocols/projectssimultaneously.

• Exercisestrategicthinkingandexecuteseffectivelyacrossprojects.

• Fostersunderstandingofculturaldifferences.

• Strongleadershipskillsthatenableanddrivealignmentwiththegoals,purposeandmissionof our company's Research Labs , Global Clinical Development (GCD) and GCTO.

• Abilitytoidentifyproblems,conflictsandopportunitiesearlyandlead,analyzeand creatively prepare mitigation plans and drive conflict resolution is critical.

• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment,2)inadequatestafftomeetbusinessneeds,3)performanceorcomplianceissues, 4)workingwithregulatoryissuesandthebroaderorganization,and 5)resolutionofconflictivesituations.

• Educational/pedagogic,diplomaticandempathicskillstoeffectivelybuildandmaintain professional relationships with investigators and other stakeholders.

Qualification&Experience:

Required:

• 10+yearsofexperienceinclinicalresearchwithdemonstratedsuccessandincreasingresponsibilitiesofwhich5+yearsconsistedofleadingprojectsandteam

• Bachelordegreein Science (orcomparable)

Preferred:

• CRAExperiencepreferred

• Advanceddegree,(e.g.,Masterdegree,MD,PhD)

• Oncology / Early Development experience preferred

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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