About BridgeBio Oncology Therapeutics

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com.

Who You Are

We are seeking an experienced Clinical Data Manager (Contractor) to support BBOT’s clinical programs from study start-up through database lock. This is a hands-on, independent contractor role responsible for data quality oversight, CRO and vendor management, and the delivery of timely, inspection-ready clinical data across BBOT’s early-phase oncology pipeline. The contractor will work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, and Regulatory teams, as well as external CROs and vendors. This is an initial contract engagement with the potential to convert to a full-time employee (FTE) role based on performance and organizational need. The weekly utilization of this position is estimated to be 40 hours a week.

Responsibilities

• Develop and maintain Data Management Plans (DMPs), data validation specifications, data review plans, and related study documentation
• Review eCRFs, edit checks, database specifications, and EDC functionality to ensure fit-for-purpose design and alignment with study requirements
• Conduct ongoing data review, identify discrepancies and trends, and manage data queries through resolution to ensure timely and complete data cleaning
• Reconcile EDC data with external data sources including central laboratory, imaging, ECG, PK/PD, eCOA, IRT/RTSM, and safety data
• Support SAE reconciliation, user acceptance testing (UAT), interim analyses, and database lock activities, ensuring all activities meet timelines and quality standards
• Monitor data transfers and oversee CRO and vendor deliverables, proactively identifying and resolving data quality, timeline, and operational risks
• Ensure compliance with applicable regulations, SOPs, study procedures, and CDISC/CDASH standards throughout all data management activities
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, CROs, and vendors to support seamless cross-functional data execution
• Contribute to the improvement of data review, cleaning, reconciliation, and database lock processes; support SOP development and process documentation as needed

Requirements

 Education and Qualifications 

• Bachelor’s degree in Life Sciences, Computer Science, Data Management, or a related field
• 5+ years of clinical data management experience in biotechnology or pharmaceutical development, including experience supporting studies through database lock
• Proficiency with Medidata Rave, Veeva Vault CDMS, or comparable EDC systems
• Experience with external data reconciliation, data transfers, edit check specifications, validation specifications, and database documentation
• Solid knowledge of clinical data standards and regulations, including CDISC/CDASH, ICH-GCP, and risk-based data management principles
• Experience managing CRO and technology vendors in a data management capacity
• Strong analytical, organizational, communication, and problem-solving skills; ability to work independently and manage competing priorities in a fast-paced biotech environment

 Preferred Experience 

• Oncology, early-phase, or first-in-human clinical studies
• Experience with IRT/RTSM, central laboratory, imaging, PK/PD, eCOA, ECG, or safety data streams
• Familiarity with data review tools, dashboards, automated checks, or AI-enabled data review platforms
• Experience building and improving data management processes in a small-to-mid-size biotech environment