Lead Clinical Data Manager

Company: Oncology-Focused Biopharmaceutical Organization
Location: Bay Area, California
Work Arrangement: Hybrid
Engagement: Contract Consulting Role

The Opportunity

Brio has partnered with an oncology-focused biopharmaceutical organization to recruit a Lead Clinical Data Manager. This consultant will own study-level data management and coordinate the activities required to deliver complete, accurate, and analysis-ready clinical data.

The Lead Clinical Data Manager will guide studies from database design and start-up through ongoing data review, cleaning, reconciliation, and database lock while maintaining alignment with clinical, statistical, and regulatory milestones.

Key Responsibilities

• Lead clinical data management activities for assigned studies from planning and database development through database lock and archival.
• Develop and maintain data management plans, data-review plans, CRF specifications, completion guidelines, and related documentation.
• Lead the design, development, testing, validation, and release of clinical databases.
• Define edit checks, data listings, query-management processes, and data-cleaning strategies.
• Coordinate user acceptance testing and document database functionality and issue resolution.
• Oversee CROs, EDC providers, and external data vendors, ensuring deliverables meet quality and timeline expectations.
• Manage external data transfers and reconciliation across laboratory, imaging, safety, biomarker, pharmacokinetic, and other vendor datasets.
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Pharmacovigilance, and Regulatory Affairs.
• Track data quality metrics, outstanding queries, protocol deviations, missing data, and study-level risks.
• Lead ongoing data-review meetings and drive issues through timely resolution.
• Coordinate database freeze and lock activities, including readiness assessments and cross-functional approvals.
• Ensure compliance with applicable regulations, CDISC standards, company procedures, and inspection-readiness expectations.
• Support regulatory submissions, audits, inspections, and continuous improvement of data-management processes.

Qualifications

• Bachelor’s or advanced degree in life sciences, data science, computer science, or a related discipline, or equivalent clinical data management experience.
• Significant clinical data management experience within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience independently leading studies from database development through lock.
• Strong knowledge of EDC systems, CRF design, edit checks, query management, data cleaning, and reconciliation.
• Experience managing CROs and specialized data vendors.
• Familiarity with CDISC standards, including SDTM, and applicable regulatory requirements.
• Experience managing complex external data involving central laboratories, imaging, biomarkers, pharmacokinetics, safety, or electronic clinical outcome assessments.
• Strong organizational, documentation, problem-solving, and cross-functional communication skills.
• Ability to independently manage priorities and maintain execution within a fast-paced consulting environment.
• Oncology, neuro-oncology, rare-disease, or late-stage clinical development experience is beneficial.
• Regulatory-submission and database-lock experience is strongly preferred.

Why Consider This Opportunity?

• Study accountability: Own clinical data delivery from database design through final database lock.
• Cross-functional partnership: Connect clinical, statistical, programming, safety, site, and vendor data requirements.
• Hands-on influence: Improve data-review processes and resolve issues affecting study and submission readiness.
• Complex data environment: Coordinate multiple external data sources across important clinical programs.
• Program visibility: Contribute directly to critical development and regulatory milestones.

Interested?

Submit your resume to Brio to learn more about the organization, its clinical programs, and the consulting engagement. Additional details regarding the work arrangement, contract duration, allocation, compensation, and complete job description will be provided following an initial resume review.

Brio Resource Group partners with emerging and established life sciences companies to recruit executives, functional leaders, and specialized professionals.