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HOW YOU’LL FLY
You’ll help to bring more patients their bluebird days by:
Oversee eTMF (electronic Trial Master File) creation, maintenance, and archiving, ensuring each are performed in accordance with Standard Operating Procedures (SOP), ICH-GCP Guidelines, EMA, FDA, and other appropriate regulations. Contribute to the integrity, completeness, and accuracy of bluebird bio’s eTMF. Continuously work in a team environment, including meeting deadlines, prioritizing, and balancing work and projects from multiple sources. Collaborate with Associate Director and Director on projects as needed. Position reports into the Somerville, MA office; however, telecommuting from a home office is allowed.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
Requires a bachelor’s in biomedical, Healthcare Informatics, Life Science, Project Management, or a directly related field plus 4 years of experience as an eTMF Manager or other occupation/position/job title involving clinical study records management and maintenance of TMF/eTMF. Experience may be gained concurrently and must include:
Four (4) years in each of the following:
follow-up.
Three (3) years in each of the following:
performing analysis of key metrics and key performance indicators (KPIs) for completeness, quality, and timeliness.
checklists; and supporting mock inspections.
Multiple positions. Apply online: https://www.bluebirdbio.com/careers.
#LI-DNI
Full Time
Durable Manufacturing
$110k-153k (estimate)
03/11/2024
05/01/2024
bluebirdbio.com
CAMBRIDGE, MA
1,000 - 3,000
1993
Public
NICK LESCHLY
$200M - $500M
Durable Manufacturing
bluebird focuses on developing transformative gene therapies for severe genetic diseases and cancer.