Clinical Trial Manager

Overview

Lead the clinical aspects of oncology clinical trials across multiple countries as a hub of central 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.
• Successfully execute assigned trials and ensure completion of trial deliverables.
• Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials by working 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 from Hungary, Poland, Romania, Serbia or Slovakia.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.