ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
eTMF Specialist (Contract)
This role is for a 12-month contract position.
ABOUT THE FLOCK
The Clinical Development flock is setting the standard for trial design, conduct, and analysis in gene therapy. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. This is not your typical development operations role – come make your mark with us!
HOW YOU’LL FLY
As an eTMF Specialist bird reporting to the Associate Director, Electronic Trial Master File, you'll help to bring more patients their bluebird days by:
- As directed by management, independently conducts Quality Control (QC) review of clinical, regulatory, safety, IRB, supply chain, labs, statistics & vendor study documentation in the eTMF to assess completeness of the eTMF, adequacy of documentation, accuracy of filing based on the Master List and DIA reference model, consistency with naming conventions, and completeness of metadata. Responsible for timely resolution of QC findings and tracking progress.
- Leads eTMF kick-off meeting for new studies, ensuring roles are assigned as per eTMF SOP. Drives the creation of eTMF Plans, and Study-specific Master Lists.
- Assists in creation, maintenance and archival of the eTMF in accordance with bluebird bio’s Standard Operating Procedures, ICH-GCP, EMA, and FDA regulations.
- Serves as primary contact for study teams regarding eTMF related processes and activities.
- Functions as eTMF representative on Clinical Study Teams.
- Supports the study teams and vendors to resolve discrepancies and ensure timely completion of internal tasks related to eTMF deliverables.
- May support by inspection activities as directed by management.
- Other related tasks as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Minimum Bachelor’s degree required in a biomedical, life science, or related field of study.
- Minimum of 3 years industry experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF
- Working knowledge of ICH-GCP, FDA, and EMA regulations.
- Knowledge of the DIA TMF reference model is preferred.
- Ability to execute tasks independently and follow-through to completion.
- Excellent organizational skills, able to multi-task in an extremely fast-paced environment.
- Ability to support several projects simultaneously, flexible working style and attention to detail are essential.
- Thrives in a dynamic environment
- Positive, outgoing and collaborative attitude
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.