Clinical Trial Manager

Overview

Lead the clinical aspects of assigned oncology trials across multiple countries as the central hub of study intelligence, 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.
• Execute assigned trials and ensure completion of trial deliverables.
• Ensure appropriate communication, regulatory documentation and ongoing oversight of assigned trials 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 and experience in a 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 English.
• 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 they relate to the execution of a clinical development plan.
• Mastery knowledge of ICH-GCP, Precision SOPs and regulatory guidance, with the ability to implement them.

Details

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