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Job #02218

About our client Our client is a US-based company focused on drug development for Neurofibromatosis Types 1 and 2, and related sporadic tumors. Neurofibromatosis (NF) is an autosomal dominant genetic disorder characterized by the development of tumors along nerves. These slow growing tumors are resistant to radiation and chemotherapy and the current standard of care is repeated surgical removal. The company was formed to pursue the treatment of NF based on recent major advances in genetic and signal transduction research. By concentrating much of the world's basic science and clinical expertise on NF in one organisation, the company is accelerating treatments to patients. Our client is the first and only company to focus on NF. Position Location Clinical Project Manager New York City Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage study activities including investigator recruitment and selection 2) Supervise study start-up, enrolment, data collection, drug projections, and reports 3) Direct study sites and train clinical site staff to ensure protocol and regulatory compliance 4) Ensure SOP and regulatory compliance of staff 5) Manage CRO selection and management, RFP development, budget negotiations, etc. 6) Manage clinical site budget and contract negotiation 7) Write study protocols, study reports, sections for investigator's brochures, regulatory documents (e.g. IND, NDA, or BLA), and monitoring plans 8) Interact with investigators and thought leaders for protocol development, presentations, and publications 9) Coordinate and participate in investigator meetings 10) Manage program budget and timelines 11) Mentor and develop junior staff 12) Plan CMC timelines and non-clinical stages Requirements 1) Hands-on experience in managing a CRO 2) 2 years’ project management experience 3) Expertise in GCP as well as GMP 4) Familiarity with all stages of bringing a drug to market