Senior Study Manager - Infectious Disease/Vaccines (Pragmatic trials) - US/Canada

Senior Study Manager - Infectious Disease/Vaccines (Pragmatic Trials) - US/CanadaICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.Senior Study ManagerMay lead or support a study or studies, depending on size/complexity. As lead, will be responsible for the following:Operational point of contact for trial execution and all trial deliverablesManages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planningManages deployment and interactions with external vendors (e.g., IVRS, PRO)Initiates planning for Investigator meeting and protocol training.Plans and assesses protocol ancillary suppliesCompletes trial set-up and maintains CTMSSchedules, prepares for, and leads the Recruitment Planning Meeting for the CTTInitiates recruitment/retention planning & enrollment tracking • Responsible for tracking study related details (e.g., specimens, queries)Oversees protocol training activities including IMs and CRAs training meetingsEnsures appropriate postings to investigative site portalsResponsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)Point of escalation for study related operational issuesResponsible for operational details at Operational ReviewsResponsible for creating and maintaining project schedule and collaborating with Program LeadSets up and maintains Trial Master File (eTMF)Ensures alignment of budget with protocol needsResponsible for executing protocol within the budgetResponsible for creating and maintaining ADI logsDevelops Site Monitoring Plan (SMP) with input from the monitoring excellence groupDevelops study related manuals (e.g., administrative binder, lab manuals)Manages Emergency Unblinding (EUB) Call Center activitiesCo-authors newsletters with CSApproves contracts, invoice payments and change orders for vendors, as necessaryResponsible for end of study reconciliation (clinical & ancillary supplies)Oversees all HQ close-out tasksResponsible for ongoing monitoring of trial activities, e.g. dashboards, trackingSupports CS activities as needed to achieve CTT deliverablesInterface with External Data Coordination and Data ManagementResponsible for quality control and inspection readiness at all timesResponsible for risk assessment, mitigation planning and executionWhat you need to have:BS/BA/MS/PhD with 7+ yrs clinical research experience Minimum Years of ExperienceMinimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.Proven ability to meet aggressive timelinesMS Project experience preferredExcellent Excel and PP skills requiredTA- Infectious disease and/or vaccines experience highly preferredGlobal experience requiredExcellent oral (including presentation) and written communication, computer/database management, and project management skills requiredHome Based position in US or CanadaAreas of direct experience:Protocol design for pragmatic trialsSite/site network selectionIntegration with healthcare systemsInformed consent approaches (simplified, eConsent, etc.)Use of EHR / real-world dataEndpoint definition (e.g., hospitalization, utilization)Central vs site monitoring approachesVendor/technology integrationRegulatory interactions / submissionsEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.Benefits may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.