Job Information
Terumo Neuro Project Manager, Clinical Research (Remote) in Aliso Viejo, California
13378BR
Title:
Project Manager, Clinical Research (Remote)
Job Description:
Involved in the design, conduct, data management, and interpretation and reporting of clinical trials. Responsible for project planning, oversight, and routine communication with the study team. Ensures clinical studies are conducted to the highest ethical and safety standards in accordance with the protocol, good clinical practices, MicroVention Standard Operating Procedures, and all applicable regulatory requirements (e.g., FDA) and guidelines.
Provide oversight to the conduct of clinical studies
Contribute to the preparation of study documentation such as protocols, amendments, case report forms, investigational plans, Investigator’s Manual, and study reports
Collect and process regulatory documents and correspondence
Prepare and ensure the accuracy of MicroVention studies posted on clinicaltrials.gov
Provide leadership to individuals responsible for the conduct of clinical studies (e.g., Clinical Research Associates and Clinical Trial Coordinators)
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
Perform additional duties as assigned
Auto req ID:
13378BR
Location MV:
Aliso Viejo, California, USA
Department Name:
652-Clinical Admin-Pre Market Operations
Qualifications:
Bachelor’s degree in Life Sciences or related field
Minimum of six (6) years of direct clinical research experience (preferably in the medical device industry), including a minimum of four (4) years of demonstrated experience in clinical research project management (preferably in the medical device industry in support of IDE studies)
Minimum of one (1) year of leadership or supervisory responsibility
Knowledge of clinical study management, terminology, and related GCP and regulatory requirements
Familiarity with the logistics of clinical design and logistical elements such as study documentation development, site selection, budget development, IRB submission preparation, training, database/CRF development, contracts, informed consent, randomization, monitoring, statistical plans, and the tracking of study metrics
Strong verbal and written communication skills
Proficiency computer skills including MS Word, Excel, Access, PowerPoint, Outlook, Teams, etc.
Domestic and International travel required (30%)
Desired Qualifications
Experience in designing and implementing clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting
Minimum of two (2) years of monitoring experience, preferably in the medical device industry
IDE clinical experience is strongly preferred, including experience in conducting global studies
An understanding of worldwide regulations governing the conduct of clinical studies
Able to handle multiple tasks efficiently and consistently, meeting deadlines
Detail-oriented
Ability to maintain strict confidentiality
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:
$116,706 - $145,882(Financial 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)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.