Project Manager, Clinical Research (Remote)

Job Description

Responsible for coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs.  

1. As a contributing member on project teams, assist in the implementation of controlled clinical studies of MicroVention products
2. Understand, read, and prepare technical documentation including, informed consents, study forms, and study training documents
3. Responsible for collecting and reviewing site regulatory documents
4. Manage device accountability process
5. Conduct Site Initiation Visits and Closure Visits at clinical study sites
6. Interface with monitors/CROs to address and resolve queries
7. Work 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)
8. Support budget and contract negotiations with clinical sites
9. Assist in writing clinical study reports by reviewing tables and listings generated from study data
10. Comply 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 organization
11. Perform additional duties as assigned

Location MV

Aliso Viejo, California, USA

Department Name

652-Clinical Admin-Pre Market Operations

Qualifications

1. Bachelor’s degree or equivalent combination of education and experience in related field
2. Minimum six (6) years of direct clinical research experience, preferably in the medical device industry, including at least two (2) years of monitoring experience
3. Knowledge of FDA regulations for clinical trials and clinical procedures
4. Strong collaborative skills with demonstrated ability to work with physicians, site coordinators and others within the company
5. Experience using technologies for clinical research (electronic data capture and clinical trial management systems)
6. Excellent written and verbal communication skills
7. Proficient computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.)
8. Travel up to 25%

Desired Qualifications

1. Bachelor’s degree in Life Science preferred
2. Clinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular)
3. Experience in the medical device industry
4. At least two (2) years of project management experience

EEO We 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 Ordinance If 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 Title

Project Manager, Clinical Research (Remote)

Posting Country

US - 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. Apply To This Job