Remote Clinical Data Manager — Contractor

BBOT; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

BBOT is a clinical-stage biopharmaceutical company seeking a Clinical Data Manager (Contractor) to support its clinical programs from study start-up through database lock in a fully remote role. This hands-on position emphasizes data quality oversight, CRO/vendor management, and timely, inspection-ready data delivery across BBOT’s early‑phase oncology pipeline.

The contractor will collaborate with Clinical Operations, Biostatistics, Medical, Safety, and Regulatory teams, as well as external CROs

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Data Management, or related field.
• 5+ years of clinical data management experience in biotechnology or pharmaceutical development, including 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.
• Strong knowledge of CDISC/CDASH, ICH‑GCP, and risk‑based data management principles.
• Experience managing CRO and technology vendors in a data management capacity.

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

Organizational

Communication

Problem-solving

Independent

Prioritization

Education

Bachelor’s degree in Life Sciences / Data Management / related field

Tools

Medidata Rave

Veeva Vault CDMS

EDC systems

Job description

BBOT is a clinical-stage biopharmaceutical company seeking a Clinical Data Manager (Contractor) to support its clinical programs from study start-up through database lock in a fully remote role. This hands-on position emphasizes data quality oversight, CRO/vendor management, and timely, inspection-ready data delivery across BBOT’s early‑phase oncology pipeline.

The contractor will collaborate with Clinical Operations, Biostatistics, Medical, Safety, and Regulatory teams, as well as external CROs