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.
ABOUT THE FLOCK
The Clinical Lab Operations flock is all about bridging the gap between our lab vendors and the Clinical team across the bbb portfolio. Whether it’s making sure data cut deadlines are met, lab processes are as smooth as possible, or finding creative solutions to meet protocol testing requirements, we are driven by our patients and our “can do” attitudes. Come work with an agile, analytical group of birds that loves rising to the challenge much as we do swapping quarantine hobbies!
HOW YOU’LL FLY
The Clinical Lab Operations Study Manager will play a pivotal role in developing the Clinical Lab Operations Oncology group and is perfect for anyone looking to combine both their scientific and project management expertise! You’ll be responsible for oversight, planning, operational implementation, and execution of clinical laboratory functions to support clinical trials.
As a Clinical Lab Operations Study Manager, you'll help to bring more patients their bluebird days by:
- Driving operational oversight of the life cycle of clinical samples (collection, sample tracking, processing, analysis, data delivery and cleaning process, and final sample disposition)
- Partnering with the Lab Vendor Manager on Central and Bioanalytical lab vendor selection. Conducting on site operational and technical visits.
- Writing Central and Bioanalytical lab related study documentation such as lab manual, vendor oversight plan, and site facing documentation
- Managing lab kit set up, central lab specifications, lab manuals, and study lab budgets
- Managing end-to-end sample tracking and logistics for clinical samples, including query/discrepancy resolution, by working closely with the CTM, central laboratories, and specialty lab vendors
- Developing data transfer agreement for lab data
- Proactively supporting the Clinical Development Operations team during data cleaning to ensure oversight of clinical samples, data transfer and reconciliation procedures
- Identifying, handling and communicating all vendor related investigations, deviations and CAPAs. Working with Compliance and QA to resolve
- Overseeing clinical lab invoices and lab budget, contract, and assay updates related to protocol schedule of events changes
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- Bachelor’s degree with Science focus
- 7+ years experience in clinical lab operations required, and 3+ years of experience in a clinical study laboratory oversight role a plus
- Experience managing clinical labs study startup a plus
- Experience with vendor operations
- Excellent organizational and problem solving skills to multi-task in an extremely fast-paced environment with tight timelines and competing priorities.
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.