... Creating and managing clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health ... to regulatory senior leadership team and other governing ...
... Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility in order to ... interact with and present to senior management at all levels, as ...
... for managing and monitoring clinical trials, ensuring compliance with regulatory requirements, ... , monitoring, and closure of clinical trials.Ensure all study protocols and ... skills.Proficiency in using clinical trial management systems (CTMS) and electronic ...
... :Relevant work experience in a clinical environment or medical setting, e.g. clinical research coordinator, nurse, medical assistant, other medical profession Basic knowledge of clinical trials, combined with in-depth knowledge ...
... liaison to project teams, CRO’s, Clinical sub-teams, and others. Maintain ... at least 5 years as clinical research scientist in oncology are ... ,000 Sites and 675,000+ Trial patients. No matter what your ...
... 5 years of experience in clinical trials. You have a knowledge of ... 5 years of experience in clinical trials. You have a knowledge of ...
... understand and summarize complex clinical data, and write and manage clinical study documents (eg, clinical study protocols, clinical study reports, and Investigators Brochures). ... in a relevant scientific clinical regulatory field.Ability to establish ...
... and programsRESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may ... .g. Investigational Medicinal Product Dossier, clinical trial justificationsMay strategically plan and perform ...
... eSource and clinical trial automation system. ClinSpark (now known as ’IQVIA Clinical eSource) improves the speed, quality and transparency of clinical research. We support a large ... developmentExperience with clinical trials, core labs or medical devices ...
... and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Discover Impactful Work:We are looking for a Senior Document Review ...