Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
Successful execution of assigned trials and ensuring completion of trial deliverables
Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
Mentoring and training of team members
Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction
Act as the hub of central intelligence for studies, overseeing clinical aspects across multiple countries and ensuring timeline adherence and quality delivery
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 or Biotech company (in a dedicated 'clinical lead' role)
Significant clinical trial management experience in the area of 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 the English language
Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
Demonstrated ability to develop positive working relationships with internal and external organizations
Core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement
Benefits
Remote work (UK, Spain, Hungary, Poland, Romania, Serbia, Slovakia)
Mentoring and training support for continued growth
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.