Clinical Trial Coordinator Manager (CTC Manager) - REMOTE

Clinical Trial Coordinator Manager (CTC Manager) - REMOTE at Merck in Boise, Idaho, United States Job Description Job Description This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH / GCP and country regulations, our Company policies and procedures and with quality standards internally and externally. Under the oversight of the CRD / Director, Clinical Research, the individual is responsible to manage / oversee a team of CTCs. As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance. The role will work across the different country operations roles (e.g. CRM, CRA-Manager, Partners, TA-Head, CRD and ) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity / resource planning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to : Hassignificantimpactonhowacountrycandelivercountry-specifictrial commitments and objectives especially during study start-up Ensureandoverseeproperon-boardingandoff-boardingofemployees,compliance to initial and ongoing trainings. TrainandoverseetheCOREcompetencies,ICH-GCPknowledge,ClinicalResearch environmentetc. AssureadherencetoGCPguidelines,processesandproceduresrelatedtodirectreports' activities and performance. Ensuredirectreportsarecomplianttothetimelinesandkeybusinessmetrics. Reviewandapprovetimesheets,GTTcompliance,expensereports,time-offrequests and provide proper oversight of CTC's productivity / utilization. Provideinputforcapacityplanning,includingreportingofcurrentmanpowerand forecasting of CTC capacity and needs, to provide efficient use of resources. Work with CRDs, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners and otherfunctionstoensureconsistencyofprocessesand protocolimplementationacross the country, to reduce variability and provide predictability. InteractswithCRMsandsitesasneededtoresolveoperationalissues,to meet commitments in a timely manner and in coordination with the study CRM and CRA. InterfacewithGCTOpartnersonclinicaltrialexecutionasassigned;includingactsaslead liaison withCTC FSP partners in facilitating coordinated process and country delivery. EscalatessiteperformanceissuestoCRMandCRD / TA-Head. PeopleandResourceManagement : Manages CTC - career development, performance reviews, etc.,including addressinglowperformancesituations,andtaking appropriateactions. Supportsandresolvesescalationofissuesfrom CTCs. Managescapacity / resourceplanningactivitiestoensureefficientallocation of resources andwork. Manage localconflicts between resource andwork. EnsuresCTCcompliancetocorporatepolicies,proceduresandqualitystandards. Skills : Demonstrates proactive leadership and must be able to in / directly influence vendors, externalpartnersandcountrymanagerstodeliverthesecommitmentswithinspecified timelines with minimal oversight from the line manager. Ability to proactively develop risk management and mitigation plans in the country and resolveissueslocally.He / sheisanindependentdecisionmakerwithaclearunderstanding of the pros and cons of each decision and takes ownership of decisions. Abilitytoworkindependentlyandinateamenvironment. Excellentpeoplemanagement,timemanagement,projectmanagementand organizational skills. Historyofstrongperformanceandleadership. Skillsandjudgmentrequiredtobeagoodsteward / decisionmakerforthecompany. FluentinLocalLanguageandbusinessproficientinEnglish(verbalandwritten). Excellent working knowledge of all applicable ICH / GCP regulations and Good DocumentationPracticesandabilitytoworkwithintheseguidelines. Expertiseinandexcellentworkingknowledgeofcoretrialmanagementsystemsandtools. Strongcoordinationandorganizationalskills. High emotionalintelligence Strongleadershipskillswithprovensuccessinpeoplemanagement Excellentinterpersonalandcommunicationskills,conflictmanagement Demonstratedabilitytobuildrelationshipsandtocommunicateeffectivelywith internal stakeholders and external partners FluencyinbothEnglishandlocallanguage Qualification & Experience : Minimum of 5 years experience within Clinical Research, preferredexperienceintheroleofCTC,CRAorsimilarrole. Linemanagementexperiencepreferredorattheminimumteamleaderexperience. Educational Requirements : Required : Bachelor'sDegree(orcomparable)inBusinessAdministration / LifeScience Preferred : Advanceddegree,(e.g.BA / BSorhigher)withastrongemphasisinscienceand / or Clinical Research Management / Administration. ResearchandDevelopmentDivisionGCTO #eligibleforerp NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Current Employees apply HERE (Current Contingent Workers apply HERE (US and Puerto Rico Residents Only : Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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