Clinical Trial Manager
5 hours ago
Description
• Manage and operational delivery of 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. • Ensure successful execution of assigned trials and completion of trial deliverables. • Maintain appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by close collaboration with other functional team members. • Mentor and train 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.
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 your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role). • 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. • Demonstrates 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.
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