Clinical Trial Manager

Role: Clinical Trial Manager (CTM) overseeing biopharma clinical programs, particularly within cell therapy and oncology. Objectives include managing the end-to-end operational execution of Phase 1-4 clinical trials to support BLA submissions, ensuring quality, safety, and compliance. Responsibilities encompass study planning, vendor management, resource allocation, risk mitigation, and data integrity oversight. The role involves cross-functional leadership, vendor selection, data review, and regular progress reporting to senior management. Qualifications include a Bachelor's degree with 5+ years in biotech/pharma, with at least 1 year as a CTM, and experience in managing early to late-phase oncology trials. Skills in global regulation adherence (ICH-GCP, FDA CFR), vendor oversight, data management, and team leadership are essential. Preferred experience in cell therapy, gene editing, or solid tumor indications is advantageous. The position is remote with emphasis on managing cross-functional teams and external vendors, requiring excellent communication, problem-solving, and regulatory knowledge.