Associate Manager, Clinical Systems & Training

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Associate Manager, Clinical Systems & Training

Clinical Systems provides global Clinical Research process harmonization management, technical systems harmonization and training related to Clinical Research. The position will regularly interface with Clinical Research globally, IT, Regulatory Compliance, Regulatory Operations, Clinical Contracts & Finance, Legal and other teams which are essential to the success of Gilead's global Clinical Research. The ideal candidate will be technology and ICH-GCP savvy; able to serve as liaison between Clinical Research and technology-related functions. The incumbent will be involved with the development of SCORM-compliant elearning, administration of local LMS functions, and will be involved with the design of instructional materials including student workbooks, handouts, leaders guides, job aids, self-study materials. Travel up to 25%.

Demonstrated knowledge of the drug development process, standard operating procedure development, problem solving, process mapping, attention to detail and process analysis experience is essential. Knowledge of Federal Drug Administration (FDA) and international regulatory requirements, International Conference on Harmonization (ICH), European Union (EU) Directive and Good Clinical Practice (GCP) Guidelines is essential. Additional requirements include experience with clinical trial protocols, study implementation and electronic and/or paper data collection.
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