Job description
ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
The Clinical Laboratory Operations (CLO) flock of birds is responsible for the central and specialty laboratory sample management across the portfolio of studies through bluebird. The CLO group plays a pivotal role in ensuring lab operation deliverables are met including data cuts, study start up and sample collections through data reporting. The CLO group works closely with the lab vendors and cross functional departments to trouble shoot any issues and provide creative solutions for ensuring smooth laboratory study management. We are driven by our patients and "can do" attitude. Come and work with a dedicated team of birds that rises to the challenge of breakthrough science and bringing curative therapies to patients!
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:
- Driving operational oversight on end-to-end tracking and logistics for clinical laboratory samples, including query/discrepancy resolution and reporting of lab results, by working closely with the clinical study manager, clinical data management, central and specialty laboratory vendors.
- Training the study team, including site monitors, on the laboratory manuals and other documents or laboratory related processes.
- Contributing to data transfer agreements for lab data and supporting the Clinical Data Management team during data cleaning to ensure oversight of clinical samples, data transfer and reconciliation procedures
- Being able to organize and prioritize across multiple often competing deliverables. Follows through on actions and tracks to resolution and closure.
- Representing Clinical Laboratory Operations cross functionally by attending study team and clinical sub‑team meetings.
- Participating or leading in the development and review of SOPs, work instructions and supporting documents.
- Performing eTMF submissions and eTMF review of the laboratory section.
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- Bachelor's degree in life science field preferred.
- 3+ years' experience in clinical laboratory operations or related field.
- Experience managing clinical laboratory activities during study startup, maintenance and close out.
- Good understanding of clinical studies and laboratory operations.
- Some experience with vendor management.
- Excellent organizational and problem-solving skills to multi-task in an extremely fast-paced environment with tight timelines and competing priorities.
- Strong reasoning, detail orientation, and problem-solving abilities are essential.
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.
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