Act as hub of central intelligence, leading CRAs and overseeing all clinical aspects across multiple countries to ensure timelines, scope, and quality delivery
Manage operational delivery including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
Ensure successful execution of assigned trials and completion of trial deliverables
Maintain appropriate communication, regulatory documentation, and ongoing oversight by collaborating with functional team members
Mentor and train team members
Identify challenges to study timelines/deliverables and propose creative action plans
Lead CRAs in site oversight including monitoring, regulatory, IP, site payment, and correspondence activities
Maintain team focus on study priorities through cross-functional partnerships to achieve high client satisfaction
Requirements
Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology
Demonstrable experience leading clinical aspects of studies across multiple countries in a CRO/Pharma/Biotech (clinical lead role)
Significant clinical trial management experience in oncology
Working knowledge of GCP/ICH guidelines and the clinical development process
Availability for domestic and international travel including overnight stays
Must be able to communicate effectively in English
Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
Demonstrates core understanding of medical terminology and clinical trial activities
Benefits
Remote work (UK, Spain, Hungary, Poland, Romania, Serbia, Slovakia)
Mentoring and training of team members
Support for continued growth
Reasonable accommodation for applicants with disabilities
Applicant Tracking System Keywords
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