Clinical Research Manager

The Clinical Research Manager (CRM) is primarily accountable for end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.Primary Duties:Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT)Responsible for project management of the assigned studiesProactively plans/drives/tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close outAccountable for performance for assigned protocols in country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externallyPerforms quality control visits as requiredReviews Monitoring Visits Reports (MVRs) and escalates performance issues and training needs to CRA manager and /or functional vendor and internal management as neededResponsible for creating and executing a local risk management plan for assigned studiesEnsures compliance with Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studiesEscalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (CQM) and or CTT (as appropriate)Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studiesCountry POC for programmatically outsourced trials for assigned protocolsServes local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets)Shares protocol-specific information and best practices across countries/clustersStrong collaboration with local/cluster roles, experience in identifying and sharing best practices across clinical trials, countries, clustersOversees accountability for country/cluster and site validations, site selection and recruitment in assigned protocolsLead and contribute to initiatives and projects adding value to the business and supporting the strategyResponsible for quality and compliance in assigned protocols in countryCoordinate study Clinical Trial Coordinator (CTC), Clinical Trial Associates (CRAs), Clinical Operation Manager (COM)Skills and Education:Bachelor's degree in Science (or comparable) required; advanced degree (Master's degree, MD, PhD) preferred5-6 years of experience in clinical researchCRA experience preferredTravel expectation is up to 30% of working time

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