Job Description

Location MV

Aliso Viejo, California, USA

Department Name

652-Clinical Admin-Pre Market Operations

Qualifications

1. Bachelor’s degree in Life Sciences or related field.
2. Minimum of eight (8) years of direct clinical research experience, including a minimum of four (4) years of experience supporting neurovascular clinical trials in the medical device industry.
3. Minimum two (2) years of personnel management experience in the medical device industry.
4. Demonstrated ability to lead teams in a matrix environment.
5. In-depth understanding of clinical study management, terminology, and related GCP and regulatory requirements.
6. Proven experience with audits and regulatory inspections.
7. Proficiency with basic study design and logistical elements such as protocol 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.
8. Strong verbal and written communication skills.
9. Proficiency in the use of MS Office products including Word, Excel, PowerPoint, Outlook, Teams, etc.
10. Proficiency in various clinical research eSystems including Meritive, Veeva, iMedNet, and others.

Desired Qualifications

1. Master’s degree in business or Life Sciences, or equivalent combination of education, training, and experience.
2. Experience in implementing clinical trials and interpreting trial results, including an understanding of data and data analysis.
3. Minimum five (5) years of monitoring experience, preferably in the medical device industry.
4. IDE clinical experience strongly preferred, including experience in conducting global studies.
5. An understanding of worldwide regulations governing the conduct of clinical studies.
6. Ability to handle multiple tasks efficiently and consistently, meeting deadlines.
7. Detail-oriented.
8. 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

Sr Project Manager, Clinical

Posting Country

US - United States

Salary Range

$140,500 - $184,500 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