Remote Clinical Data Manager (Contractor) - Oncology Trials

Paylocity; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

BridgeBio Oncology Therapeutics seeks an experienced Clinical Data Manager (Contractor) to support clinical programs from start‑up through database lock. You will ensure data quality, manage CROs and vendors, and deliver inspection‑ready data across early‑phase oncology programs.

Weekly hours ~40, with potential for full‑time conversion. The role collaborates with Clinical Operations, Biostatistics, Medical, Safety and Regulatory teams to maintain CDISC/CDASH standards and timelines in a

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.
• 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.

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.

Skills

Analytical skills

Organizational skills

Communication skills

Problem-solving

Independence

Education

BSc Life Sciences

Tools

Medidata Rave

Veeva Vault CDMS

EDC systems

Job description

BridgeBio Oncology Therapeutics seeks an experienced Clinical Data Manager (Contractor) to support clinical programs from start‑up through database lock. You will ensure data quality, manage CROs and vendors, and deliver inspection‑ready data across early‑phase oncology programs.

Weekly hours ~40, with potential for full‑time conversion. The role collaborates with Clinical Operations, Biostatistics, Medical, Safety and Regulatory teams to maintain CDISC/CDASH standards and timelines in a