Study Startup Lead

hace 2 semanas


Bogotá, Bogotá D.E., Colombia Psi A tiempo completo
Job DescriptionTake your career to the next level and be involved in study startup processes in Colombia.

You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.

Home-basedYou will:Oversee and coordinate the processes critical for clinical trial sites activationCommunicate with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters till the moment of site activationSupport site identification and selection processCollect, review, and submit documents for ethics and regulatory review and approvalPrepare packages of site documents for drug release to clinical sitesDevelop and negotiate site contracts and budgetsMonitor startup metrics and timelinesCoordinate initiatives for startup process improvement, analyze best practices and challengesQualificationsCollege/University degree or an equivalent combination of education, training and experienceMinimum 3 years of industry experience in clinical research with practical startup experience in the Country/ RegionExcellent knowledge of ICH GCP, local laws and applicable regulations in the regionFull working proficiency in English and SpanishCommunication and organizational skillsAbility to negotiate and build relationships at all levelsExperience in mentoring and leadership is preferred
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