Responsibilities:

·    Monitor oversight clinical studies

·    Manage the clinical trials monitoring team

·    Interact with investigators nationwide and internationally to promote participation in clinical trials and enrollment        of patients

·    Contribute to clinical and regulatory communications, ensuring compliance with FDA regulations, GCPs and       company SOPs in all clinical operations activities

·    Assist in the development of systems for Pharmacovigilance and data management

·    Write final study reports on completed trials

Experience Required:

·    M.D., PharmD, or Bachelor's or Master's degree in life sciences, pharmacy, nursing or RN

·    10+ years clinical research experience in the biotech/pharmaceutical industry

·    Experience in managing oncology clinical trial operations and data management

·    Personnel management experience required

·    Proven ability to build a successful team and to motivate and direct staff

·    Demonstrated experience in project management of teams across multiple functional areas

·    Strong interpersonal skills and the ability to build relationships both internally and with sponsors

·    Knowledge of ICH/GCP and federal regulations

·    Extensive acumen in problem solving, juggling multiple priorities

·    Commitment to quality and customer focus

·    Excellent verbal and written communication skills

·    Professional appearance and exceptional public speaking skills

·    Computer proficiency (Word, Excel, Outlook, PowerPoint) essential

·         Willing to travel (20-30%) throughout the United States and internationally