Job Description
Title:ClinicalProjectManager(CPM) Reports to:Chief Operations Officer (COO) Key Requirements Science and/or medical or nursing background. Minimum5yearsClinicalResearchexperience,oncologyanadvantage. Provenabilitytodeliverprojectgoalsandmentorjuniorlevelemployees. In-depthknowledgeoftheIrishclinicaltrialsenvironment. ExperiencewithdraftingandmanagingClinicalTrialbudgetsanadvantage. Excellent communication skills with the ability to represent the company at an international level. Main Function(s) Maintain knowledge and ensure conduct of assigned studies is in compliance with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures. Manage successful execution of multiple projects and lead cross-functional project teams. Primary Responsibilities Manage assigned studies from concept to final study report in line with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures. Developandmaintainstrongrelationshipswithexternalstakeholderstoidentifynewstudies and manage ongoing collaborations. Contributetotheoversightandexecutionofkeyoperationalstrategiesandprocesses. LeadprotocoldevelopmentforassignedstudiesandliaisewiththeCancerTrialsIrelandStudy Start-up team as required. Developandexecutestudyplansincludingsettingprojectgoals,leadingriskassessmentand management, planning resources and timelines, and study team oversight. Manageroleandproject-specifictraining. OverallresponsibilityformanagementofessentialdocumentsandTrialMasterFilerelatedto assigned studies. Overseetheprocessofsitevisitsanddocumentationofthevisits. Pre-emptivelyidentifypotentialissuesandproactivelymanageresolutionsandputinplace, where possible, measures to minimise issues and risk for assigned studies. Contribute to preparation for audits and inspections, conduct, and follow-up as required both internally and at investigational sites for assigned studies. Assistasrequiredwithdraftingandfinalisingbudgetsandrolesandresponsibilitiespriorto commencing study activities and manage throughout the lifecycle of the study. Takeallreasonableprecautionstoensurepatientconfidentialityismaintained. Contributetodepartmentalandcross-functionalSOPdevelopmentandupdatesasrequired. UpdateCOOonthestatusofallclinicaltrialactivities. IdentifyandcommunicatescientificmisconductaccordingtoCancerTrialsIrelandpolicies. Perform other tasks as specified by COO.