With singular focus, QED, a subsidiary of BridgeBio Pharma, is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders.
FGFR=fibroblast growth factor receptor.
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country.
Who You Are
The Clinical Data Manager position is responsible for the day-to-day clinical data management operations and functions associated with a clinical trial database. The primary responsibilities include study start-up activities, study conduct, and study database closeout. Addition responsibilities include discrepancy management, data review, project support, and study document management. The position will perform duties in compliance with the study protocol, QED standards/SOPs, and Good Clinical Data Management Practices (GCDMPs).
- Responsible for and/or participate in the study start-up activities for a clinical trial database, including database design, programming and validation, and maintenance for clinical study databases to ensure accurate data collection and compliance with QED data standards/SOPs.
- Participate in the review and design of CRFs and CRF completion guidelines.
- Participate in the logic and/or reviews edit check specification to facilitate the cleaning of clinical data.
- Coordinate and perform user acceptance testing (UAT) of the clinical trial database.
- Assist in the creation, review, and oversight of document life cycles such as Data Management Plans (DMPs), eCRF completion guidelines, and data review plans for completeness and consistency.
- Manage third-party vendors and the creation of data transfer specifications and the receipt of external data transfers.
- Participate in mid-study updates, including UAT and pre-go-live activities
- Responsible and/or participates in the study conduct activities for a clinical trial database, including reviewing the clinical trial data for completeness and correctness, querying sites for problems, issues, or trends, and escalating within clinical as appropriate; reconciliation of external data (e.g., laboratory data, serious adverse events) with the clinical trial database
- Participate in the medical coding activities and liaise with our coding vendor to produce coding listings. Interact with the study team to resolve any coding queries from the vendor
- Participates in regular data review activities with the clinical team to ensure accuracy, consistency, and reliability of data; may oversee personnel performing data entry, data reconciliation, and data discrepancy resolution tasks
- Participates in study closeout activities working with the clinical study team and/or CRO per project timelines
- Participates in the review and development of policies and SOPs in Clinical Data Management and Biometrics
- Works with Lead Clinical Data Managers and assist them with their clinical studies
- Participate, as directed by the Head of Clinical Data Management, on any other clinical data management directives and company priorities
Education, Experience & Skills Requirements
- Minimum Bachelor’s degree in computer science or related field is preferred but not required
- At least 2+ years of relevant clinical data management experience in pharmaceutical, biotech, CRO, or other clinical research environments. CCDM certification preferred
- Experience with a clinical trial database using EDC systems
- Demonstrated ability in reviewing and developing study documents, particularly CRFs, edit check specifications, and DMPs
- Experience with IRT/IXRS, ePRO/eDiary, medical coding, and SAE reconciliation preferred
- Working knowledge of GCP, ICH, FDA, and HIPAA regulations and guidelines
- Some familiarity with CDISC standards, including CDASH, SDTM controlled terminologies, aCRF, cSDRG, and define
- Ability to work independently, self-directed, as well as collaboratively in a team environment
- Excellent organizational, written, verbal, and interpersonal communication skills with great attention to detail; demonstrated ability to communicate with non-data focused people
- Ability to work proactively and effectively in a fast-paced, high change environment
- Excellent computer skills and proficient in the use of Adobe Acrobat and Microsoft Office products
- Experience with CRO and/or vendor management a plus
- Travel 10%
What We Offer
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
- Learning and development training to help employees be the best version of themselves
- Collaborative business environment
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
- Excellent benefits package
- Flexible PTO
- With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
- A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
- Work with the most productive groups of R&D operators in the industry
- Partnerships with leading institutions
- A platform for meaningful scientific contributions to shine
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so