Project Manager, Clinical Research (Remote)

Job DescriptionResponsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. As a contributing member on project teams, assist in the implementation of controlled clinical studies of MicroVention productsUnderstand, read, and prepare technical documentation including, informed consents, study forms, and study training documentsResponsible for collecting and reviewing site regulatory documentsManage device accountability processConduct Site Initiation Visits and Closure Visits at clinical study sitesInterface with monitors/CROs to address and resolve queriesWork closely with Project Manager(s) to ensure clinical studies are conducted in accordance with the protocol, GCP, MicroVention SOPs, and all applicable regulations (e.g., FDA)Support budget and contract negotiations with clinical sitesAssist in writing clinical study reports by reviewing tables and listings generated from study dataComply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organizationPerform additional duties as assignedLocation MVAliso Viejo, California, USA Department Name652-Clinical Admin-Pre Market Operations QualificationsBachelor’s degree or equivalent combination of education and experience in related field Minimum six (6) years of direct clinical research experience, preferably in the medical device industry, including at least two (2) years of monitoring experienceKnowledge of FDA regulations for clinical trials and clinical proceduresStrong collaborative skills with demonstrated ability to work with physicians, site coordinators and others within the companyExperience using technologies for clinical research (electronic data capture and clinical trial management systems)Excellent written and verbal communication skillsProficient computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.)Travel up to 25%Desired QualificationsBachelor’s degree in Life Science preferredClinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular)Experience in the medical device industryAt least two (2) years of project management experienceEEOWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.Fair Chance OrdinanceIf you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.External-Facing TitleProject Manager, Clinical Research (Remote)Posting CountryUS - United States Salary Range$100,064-$125,080Financial compensation packages may be higher/lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

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