Manager, Clinical Data Management

Location MV

Aliso Viejo, California, USA

Department Name

652-Clinical Admin-Pre Market Operations

Qualifications

1. Bachelor’s degree in life sciences, health sciences, or computer sciences field or equivalent combination of education, training, and industry related experience.
2. A minimum of seven (7) years of clinical data management experience in the pharmaceutical, medical device, or Clinical Research Organization setting.
3. A minimum of one (1) year of management or supervisory experience.
4. Proven track record of strong project management skills and experience managing data management activities.
5. Experience in vendor selection and management.
6. Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives.
7. Advanced understanding of clinical data lifecycle including database design, data structure, database development and testing, query management, data quality review, and database lock procedures.
8. Excellent written and verbal communication skills.
9. Strong proficiency with Microsoft Office (e.g., Visio, PowerPoint, Word, Excel, Access, Outlook, Teams, etc.).
10. Advanced understanding of ICH, ISO, GCP, and GDP guidelines.

Desired Qualifications

1. Advanced knowledge in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.
2. Hands-on experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission. 
3. Ability to identify data trends, problems and delays and escalate them appropriately to minimize their impact to the study.
4. Experience in working with CROs/EDC vendors for data management activities. 
5. Highly organized with the ability to prioritize and manage multiple activities concurrently.

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

Manager Clinical Data Management

Posting Country

US - United States

Salary Range

$129,075-$161,344 Financial compensation packages may be higher or 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