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Job #02520

About our client Our client is a New Jersey-based biopharmaceutical company, incorporated in the early part of this century. They are committed to improving health through advancements in life science and technology. This dedication to human health has given impetus to the discovery and development of a technology that has the potential to improve the effectiveness of antibody-based treatments across many therapeutic categories. Position Location Clinical Trial manager New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare, study specific documents, guidelines and general clinical-related documents 2) Manage clinical supply shipments and inventory 3) Oversee study tracking, status reports, update project timelines 4) Manage direct vendor management of external service providers 5) Contribute to client's multidisciplinary team approach to continuous improvement Requirements 1) BS or MS in Health Care or Life Sciences discipline 2) Knowledge of advanced clinical trial design 3) Basic statistics and pharmacokinetics knowledge a plus 4) 5+ years of hands-on clinical operations experience in the biopharmaceutical industry, specifically in monoclonal antibodies or biologics 5) Experience in writing pre-IND and IND documents along with annual reports to the FDA and clinical study report 6) Antibodies experience 7) Ability to analyze and interpret drug efficacy and safety data 8) Proven ability to work in a cross-functional team environment 9) Strong medical/scientific writing skills 10) Willingness to travel – up to 10% (co-monitoring visit with the CRO)