ID
#20186181
Job type
Permanent
Salary
$80,000 - $120,000 per year
Source
Jobot
Date
2021-09-23
Deadline
2021-11-21

Clinical Data Management Associate (REMOTE)

Washington, Seattle-tacoma, 98101

Permanent

Vacancy expired!

Clinical Data Management Associate needed for nationally recognized medical device company!

This Jobot Job is hosted by: Adam AnaimAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $80,000 - $120,000 per year

A bit about us:

Founded over 10 years ago and growing at an extremely rapid pace, we are a well-funded medical device company that is seeking a Clinical Data Management Associate to join our team. This individual will be in charge of performing data management activities and meeting clinical study objectives in compliance with the study protocol, SOP, GCP, and GCDMP. Come join the fun and see what we're all about!

Why join us?

Opportunity for advancement!
Competitive pay structure!
Excellent benefits package!
Great company culture!

Job Details

Work with cross-function members and vendors to design, test and implement data collection systems, such as EDC, CTMS, and eTMF systems
Ensure data management execution is compliant with CRF 21 Part 11, ICH GCP, Good Clinical Data Management Practices
Oversee clinical data management activities across multiple studies
Complete data management activities to meet all study timelines from study start up, database build to database lock
Perform thorough reviews of clinical protocols, eCRF specifications, CRFs and annotated CRFs, edit check specifications, online screen review, data review plan and application review logs
Work closely with clinical team members to prepare and ensure proper execution of data management plans and activities from beginning to end
Perform User Acceptance Testing on new or modified clinical study databases
Ensure all database modifications are communicated with team and implemented effectively
Assist or develop project-specific data management plans that address areas such as data coding, deleting, reporting or transfer, database freezes, locks and workflow processes
Perform manual data listing and query reviews, identifying data trends and/or issues, ensuring database updates are applied
Facilitate final team review of data and review documentation for database locks
Work with cross-functional teams to ensure all non-data management activities related to database lock are completed in a timely manner

QUALIFICATIONS:

Bachelor of Science degree required
Medical device experience preferred
Clinical Data Management Certification preferred
3+ years of clinical trials data management experience in the biotechnology/biopharmaceutical industry
Knowledge of FDA Regulations, ICH and ISO Guidelines, GCP, and Good Clinical Data Management Practices
Experience with various data collection and EDC, eTMF, and CTMS systems
Ability to multi-task and shift priorities quickly while working under tight deadlines

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Vacancy expired!

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