As Senior Global Trial Manager, you will contribute to all aspects of the assigned clinical trial(s) to deliver study outcomes within schedule, budget, quality, compliance, and performance standards. You will lead specific aspects of global clinical trials and become a core member of the Clinical Trial Team (CTT).Key Responsibilities :
Developing specific sections of the protocol and related documentsDeveloping study tools, guidelines, and training materialsContributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports, and trial statistical analysis plans in collaboration with data managers, statisticians, and programmersContributing to the development of clinical sections of regulatory documents such as Investigators’ Brochures and safety updatesProject Management :
Ensuring trial information / results are reported within relevant repositories and tracking systemsSupporting forecast and management of drug supply in collaboration with stakeholdersImplementing issue resolution plansHandling study close-out activities, including site close-out, drug accountability, and audit readinessManaging and tracking the trial budget, including forecasts and cost targetsDefining and participating in the Data Review PlanSupporting Managed Access Program management, including physician requests and complianceDeveloping outsourcing specifications and managing vendor relationships to ensure quality standardsInternal and External Collaboration :
Organizing and logistics of trial advisory committeesServing as point of contact for site-related issues and procedural questionsManaging interactions with line functions such as data management and drug supplyReporting study progress and issues at CTT meetings, including writing minutes and leading sub-teamsQualifications :
Advanced degree in life sciences or healthcare preferred2-5 years of experience managing late-phase global clinical trialsExperience with Non-Interventional Studies, post-marketing studies, and regulatory safety documentsStrong background in protocol development and study startupExcellent communication, organization, and tracking skillsNetworking skills and ability to share knowledgeKnowledge of Good Clinical Practice and clinical trial designEnthusiasm for late-phase studiesIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We value diversity, inclusion, and belonging, fostering a culture of innovation and collaboration to improve patient outcomes worldwide.
J-18808-Ljbffr
#J-18808-Ljbffr