Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)Join to apply for the Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe) role at PharmiWeb.Jobs :
Global Life Science JobsGlobal Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)2 days ago Be among the first 25 applicantsJoin to apply for the Global Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe) role at PharmiWeb.Jobs :
Global Life Science JobsJob PurposeAs 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 trial(s) and will become core member of the Clinical Trial Team (CTT).Job PurposeAs 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 trial(s) and will become core member of the Clinical Trial Team (CTT).Key ResponsibilitiesDevelopment of specific sections of the protocol and related documents;
Development of study tools, guidelines and training materials;
Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, and statistical programmer;
Contributing to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc.Project ManagementEnsuring trial information / results are reported within relevant trial repositories and tracking systems (e.G. trial results registries);
Supporting forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders;
Implementing issue resolution plans;
Ensuring proper handlingof all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.Supporting with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets.Contributing to defining the Data Review Plan;
participate in data review as specified in the Data Review PlanSupporting Management of Managed Access Program as assigned. Support Management of physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs);
managing interface withCROs in cooperation with outsourcing management and line functions;
ensuring vendors meet quality standards;
contributing to the development / amendment of vendor contracts;
Internal And External CollaborationOrganization and logistics of various trial advisory committees (e.G. Data Monitoring Committee, Steering Committee);
Acting as point of contact for all site-related issues and procedural questions;
Managing interactions with relevant line functions e.G., data management, drug supply management, etc.;
Participating and reporting study progress and issues / resolution plan at the CTT meeting;
write CTT meeting minutes. Organizing and chairing trial sub teams.Ideal BackgroundAdvanced degree or equivalent education / degree in life science / healthcare recommended;
2-5 years of experience in managing late phase clinical trials at global level;
Experience managing Non-Interventional Studies (NIS) :
registry studies, phase IV studies, and post-marketing studies. Post-authorization safety or efficacy studies (PASS or PAES)Experience with providing inputs into regulatory and safety documents required for Health Authority submission. Experience in development of safety update reports (PSUR / DSUR), investigator brochure (IB), addendum to clinical overviews (ACO), new drug application annual report (NDA AR), biological license application annual report (BLA);
Good background of protocol development / study start up;
Excellent communication,organization and tracking skills;
Proven networking skillsand ability to share knowledge and experience amongst colleagues;
Knowledge of Good Clinical Practice;
comprehensive knowledgeof clinical trial design;
understanding of the overall drug development process;
Enthusiasm and passion for late phase studies.IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionJob functionResearch, Analyst, and Information TechnologyStaffing and RecruitingReferrals increase your chances of interviewing at PharmiWeb.Jobs :
Global Life Science Jobs by 2xGet notified about new Trial Manager jobs in Madrid, Community of Madrid, Spain .Clinical Project Manager / Senior Clinical Project ManagerClinical Project Manager / Senior Clinical Project ManagerMadrid, Community of Madrid, Spain 1 week agoGlobal Trial Manager, Late Phase Studies, Single-Sponsor Dedicated (home-based in Europe)Madrid, Community of Madrid, Spain 3 days agoMadrid, Community of Madrid, Spain 1 month agoMadrid, Community of Madrid, Spain 2 weeks agoClinical Research Associate II / Sr. CRA, SpainMadrid, Community of Madrid, Spain 2 weeks agoSenior Project Manager, Early Phase (Spain)Madrid, Community of Madrid, Spain 1 month agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.J-18808-LjbffrJ-18808-Ljbffr
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