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Job #02327

About our client Our client is small publicly traded pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various oncology, cardiovascular and inflammatory disease therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Project Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee, manage and coordinate clinical sites and contracted vendors from study start up through clinical study report completion 2) Manage timelines, resources, patient recruitment and tracking, drug supply, and other clinical documents and regulatory filings (Investigator Brochures, Annual IND Safety Reports, Integrated Clinical Study Reports, etc.) 3) Track and manage clinical site payments and budget expenditures 4) Maintain clinical study master files and all clinical trial management materials 5) Support clinical monitoring and investigative site activities to ensure high quality data in a timely fashion 6) Perform a leadership role in maintaining clinical operations standards 7) Ensure compliance with GCPs, GLPs and ICH guidelines, company SOPs, and tracking budgets Requirements 1) Bachelor’s degree 2) 2 years of experience in managing research projects in the biotech/pharmaceutical industry 3) Knowledge of FDA Regulations and ICH guidelines a plus 4) Strong attention to detail and follow up 5) Sense of urgency and commitment 6) Ability to work independently as well as in a team environment 7) Excellent written and communication skills