Lead and oversee daily operations for assigned clinical studies, ensuring timely completion within established goals, regulatory guidelines, and project objectives
Manage cross-functional study teams (including vendors), collaborating with preclinical development, regulatory affairs, and project management to coordinate clinical study activities
Maintain study timelines, proactively addressing and escalating potential delays to project management
Conduct and oversee study monitoring visits, providing regular progress updates to stakeholders and resolving study-related issues
Implement and maintain quality standards across investigative sites, vendors, and data management, ensuring compliant clinical study files
Lead vendor selection and manage vendor relationships, conducting feasibility assessments for country and site selection
Oversee clinical data cleaning, analysis, and reporting, participating in data reviews and statistical analysis planning
Review and edit data summaries, presentations, training materials, and study documents
Develop and implement effective training programs for investigators, site monitors, and internal/external study teams
Required Qualifications: BSc Nursing degree with at 15 plus years in the same field
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability