Clinical Trial Manager

Overview

Lead the clinical elements of oncology clinical trials across multiple countries as the central point of study management, leading CRAs and ensuring timeline adherence, scope and quality delivery.

What you'll do

• Manage and operationally deliver the clinical elements of a trial, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
• Successfully execute assigned trials and ensure completion of trial deliverables
• Ensure appropriate communication, regulatory documentation and ongoing oversight of assigned trial(s) in close collaboration with other functional team members
• Mentor and train team members
• Identify challenges to study timelines and deliverables and offer creative action plans to the team and 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

What you'll need

• 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, as well as CAR-T and Radiopharmaceuticals
• Working knowledge of GCP/ICH guidelines and the clinical development process
• Availability for domestic and international travel including overnight stays
• Ability 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
• Demonstrated core understanding of medical terminology and clinical trial activities as it relates to execution of a clinical development plan
• Mastery knowledge of ICH-GCP, Precision SOPs and regulatory guidance, and the ability to implement them

Details

• Remote work from Hungary, Poland, Romania, Serbia or Slovakia
• Candidates must be legally authorized to work in the country of employment without employer sponsorship