About BridgeBio
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aim to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. To learn more about our story and company culture, visit us at https://bridgebio.com
Who You Are
The Associate Director, Clinical Data Management will be responsible to support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications
Responsibilities
- Leads all clinical data management activities for one or more clinical studies
- Oversees the creation and approval of Data Management study documentation by CROs and other vendors, to include CRFs, completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans
- Understands all aspects of the study protocols and statistical analysis plans as they relate to data management deliverables and serve as a knowledgeable point person on study teams for data management activities
- Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites and potential risks to timelines
- Reviews the deliverables of data management vendors to ensure accuracy and consistency with expected practices
- Coordinates cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings and communication of post-review status
- Produces regular data listings for the clinical team and other functional areas
- Meets study timelines with a high degree of quality
No matter your role at BridgeBio, successful team members are:
- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills Requirements
- Bachelor’s degree (or equivalent) in relevant scientific discipline preferred
- Minimum of 7 years of data management experience in the biotech, pharmaceutical and/or CRO setting; as well as experience with global studies
- Skills present in core data management activities (e.g., data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting)
- Knowledge of CDISC and SDTM standard terminology
- Knowledge of ICH GCP and Good Clinical Data Management guidelines
- Experience working with an Electronic Data Capture system (EDC) (e.g. Medidata Rave) and with other databases (e.g. Central Imaging, IVRS/IWRS)
- Proficient with MS Word, Excel and PowerPoint
- Strong interpersonal, communication (written and verbal), and organizational skills
- Demonstrated ability to work independently, as well as part of a multifunctional study team
What We Offer
- Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
- An unyielding commitment to always putting patients first. Learn more about how we do this here
- A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
- A place where you own the vision – both for your program and your own career path
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
- Access to learning and development resources to help you get in the best professional shape of your life
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
- Flexible PTO
- Rapid career advancement for strong performers
- Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.
BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.Salary$175,000—$220,000 USD
