Clinical Project Lead
26 minuti fa
Clinical Project Manager – Neuro / Psychiatry Location DepartmentClinical OperationsReports toSenior Clinical Project Manager / Director of Clinical OperationsJob PurposeThe Clinical Project Manager (CPM) is responsible for the planning, execution, and delivery of clinical trials within Neurology and Psychiatry, ensuring studies are conducted on time, within budget, and in compliance with ICH-GCP, EU regulations, and company SOPs.The CPM will lead cross-functional teams and act as the primary operational contact for sponsors, CRO partners, and internal stakeholders.Key ResponsibilitiesClinical Trial ManagementLead the operational management of Phase I–IV clinical trials in Neurology and/or PsychiatryDevelop and maintain project plans, timelines, budgets, and risk mitigation strategiesEnsure trial delivery meets quality, timeline, and financial objectivesOversee study start-up, site activation, enrolment, monitoring, and close-out activitiesCross-Functional LeadershipCoordinate internal teams including Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Regulatory AffairsManage external vendors, CROs, central laboratories, and imaging providersChair study team meetings and ensure clear communication across all stakeholdersSupport site selection, feasibility assessments, and investigator engagementMonitor site performance, enrolment, and protocol complianceAddress operational challenges related to Neuro/Psych populations (e.g. recruitment, retention, patient burden)Regulatory & Quality ComplianceEnsure trials comply with ICH-GCP, EU Clinical Trial Regulation (CTR), GDPR, and local Italian regulatory requirementsSupport submissions to Ethics Committees and Competent AuthoritiesEnsure inspection and audit readiness throughout the study lifecycleBudget & Financial ManagementDevelop and manage study budgets and forecastsTrack study spend and manage change ordersEnsure timely investigator payments and vendor invoicingIdentify operational risks early and implement mitigation strategiesEscalate issues appropriately and provide clear solutions to stakeholdersLead corrective and preventive actions (CAPAs) when requiredTherapeutic Area Focus – Neuro / PsychiatryManage trials involving CNS indications such as neurological disorders, psychiatric conditions, or neurodevelopmental diseasesOversee complex assessments (e.g. rating scales, cognitive testing, imaging, digital endpoints)Ensure patient-centric approaches for vulnerable populations and long-term studiesPerson SpecificationBachelor's degree in Life Sciences, Nursing, Pharmacy, or a related disciplineProven experience as a Clinical Project Manager or Senior Clinical Trial ManagerStrong experience managing Neurology and/or Psychiatry clinical trialsIn-depth knowledge of ICH-GCP and EU clinical trial regulationsDemonstrated ability to manage multiple studies and cross-functional teamsExcellent communication, leadership, and organisational skillsFluency in English (written and spoken)Experience working in Italy and familiarity with AIFA and Ethics Committee processesCRO and/or sponsor-side experienceExperience with decentralised or hybrid trial designsMaster's degree or project management certification (e.g. PMP, PRINCE2)Fluency in ItalianWhat We OfferOpportunity to work on innovative CNS clinical trialsInternational and collaborative working environmentCompetitive salary and benefits packageProfessional development and career progression opportunities#J-*****-Ljbffr
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