Clinical Project Manager

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
? Under general supervision, contributes to the design, planning, and monitoring of research programs conducted by the Medical Affairs department (e.g., post-approval studies, investigator initiated trials, registries, and non registration studies) in accordance all applicable guidelines, regulations, company procedures and high ethical/quality standards
? Assist with the writing of protocols, case report forms, informed consents, monitoring procedures and other study related documents
? Coordinate activities related to adverse event/complaint reporting
? Assist with data coordination/management and reporting/communication of results (e.g., publications, presentations, communication materials)
? Assist in the evaluation and management of vendor performance during conduct of assigned trials.
? Interface effectively with internal and external customers
? Participate in developing department procedures and best practices
? Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

EDUCATION and/or EXPERIENCE: Bachelor?s degree or higher and 2 or more years of related experience and/or training or equivalent combination of education and/or experience.

OTHER SKILLS and ABILITIES: CRO or industry experience as a clinical research associate (or equivalent) for devices and/or drugs is essential. Experience conducting post-approval studies, registries, and/or investigator initiated studies is preferred. Experience with cardiovascular and/or endovascular trials preferred. Proficiency in current computer programs (e.g., PowerPoint, Excel and Word) required. Strong written and oral English communication skills required. Working knowledge of GCP regulatory guidelines and clinical trial processes. Effective time-management and organizational skills. Flexibility and results orientation. Overnight travel required (approximately 30%).