BridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Backed by Sequoia.
About the role
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
What they're looking for
- 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience supporting global clinical trials
- Understanding of the drug development life cycle
- Experience in handling clinical trial-related documents required
- Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents
- Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
- Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment
More about this role
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
ML Bio Solutions is searching for an experienced TMF Operations Lead to develop and implement the strategy for ensuring completeness and accuracy of the TMF for all...
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