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Overview:
- The Clinical Trial Manager has operations experience within the biotech/biopharma arena.
- This individual has a high level of core competencies and technical skills applied within management of clinical programs leading to registrational submissions.
Essential Functions:
- Support overall operational execution of clinical studies on one or more clinical programs.
- Manage implementation, on-time execution and conduct of clinical studies, including budget, milestones, and vendor selection.
- Oversee cross-functional study team members to ensure program execution within approved budget and timelines.
Required Qualifications:
- Bachelor’s degree with 5+ years of pharmaceutical or biotech-related clinical research experience and at least 1 year as CTM.
- Demonstrated experience in designing, initiating, and managing phase 1-4 clinical trials.
- Expertise in US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR).
Iovance Biotherapeutics
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.