Company
Biotech
DataQualityLead/DataManagementLead-Oncology
Neural analysis suggests this role is
optimal for Lead candidates.
“Data Quality Lead / Data Management Lead - Oncology. Skills: Data management, Data quality, Oncology trials, CDISC standards. Lead data management strategy and execution. Ensure high-quality data delivery”
What You'll Achieve.
High-quality data delivery; Compliant data delivery; Timely data delivery; Database lock; Maintain data integrity
Industry & Context.
Problem-solving; Identify issues; Drive mitigation plans; Resolve variances; Resolve scope changes
Alignment to Pacific Time Zone hours
What They're Looking For.
Must Have
Bachelor’s or Master’s degree in Life Sciences, Data Science, Computer Science, or equivalent industry experience, 7+ years of clinical data management or biometrics experience, Leadership of data management study teams, Knowledge of oncology clinical trials, Deep understanding of CDISC standards, Deep understanding of ICH-GCP, Deep understanding of regulated clinical research environments, Proven experience in vendor oversight, Proven experience in CRO collaboration, Proven experience in cross-functional stakeholder management, Analytical skills, Project management skills, Problem-solving skills, Ability to manage competing priorities, SQL proficiency, SAS proficiency, R proficiency, Python proficiency, Tableau proficiency
Nice to Have
Late-phase (Phase IIIB–IV) oncology studies experience, Solid tumor studies experience, PhD preferred
What You'll Do.
Lead data management strategy and execution
Ensure high-quality data delivery
Ensure compliant data delivery
Ensure timely data delivery
Oversee data collection
Oversee data cleaning
Oversee data reconciliation
Oversee database lock
Develop data quality strategies
Implement data quality strategies
Identify issues proactively
Drive mitigation plans
Partner with cross-functional teams
Partner with external vendors
Ensure data standards are met
Ensure timelines are met
Ensure contractual obligations are met
Monitor study health metrics
Identify trends or anomalies
Drive corrective actions
Maintain data integrity
Ensure compliance with CDISC standards
Ensure compliance with ICH-GCP guidelines
Ensure compliance with regulatory requirements
Support integration of multiple data sources
Ensure structured datasets
Ensure analysis-ready datasets
Contribute to financial oversight
Contribute to resource oversight
Contribute to timeline oversight
Resolve scope changes
How You'll Work.
Team & Collaboration
Cross-functional teams; External vendors; CRO collaboration; Multidisciplinary teams
Communication Scope
Influence; Mentor; Guide
Process & Methodology
Project management, Timeline oversight, Scope changes
Full Job Description
## Accountabilities Lead data management strategy and execution across oncology clinical trials by ensuring high-quality, compliant, and timely delivery of study data. Oversee end-to-end clinical data management activities including study setup, data collection, cleaning, reconciliation, and database lock. Develop and implement risk-based data quality strategies, proactively identifying issues and driving mitigation plans. Partner with cross-functional teams and external vendors/CROs to ensure data standards, timelines, and contractual obligations are met. Monitor study health metrics, identify trends or anomalies, and drive corrective actions to maintain data integrity. Ensure compliance with CDISC standards, ICH-GCP guidelines, and applicable regulatory requirements in all data processes. Support integration of multiple data sources, including ancillary systems, ensuring structured and analysis-ready datasets. Contribute to financial, resource, and timeline oversight for assigned studies while resolving variances and scope changes. Requirements: This role requires strong expertise in clinical data management within pharmaceutical or biotech environments, particularly in oncology studies. Bachelor’s or Master’s degree in Life Sciences, Data Science, Computer Science, or equivalent industry experience. 7+ years of clinical data management or biometrics experience, including leadership of data management study teams. Strong knowledge of oncology clinical trials, ideally including late-phase (Phase IIIB–IV) and solid tumor studies. Deep understanding of CDISC standards, ICH-GCP, and regulated clinical research environments. Proven experience in vendor oversight, CRO collaboration, and cross-functional stakeholder management. Strong analytical, project management, and problem-solving skills with the ability to manage competing priorities. Familiarity with data analytics tools (e.g., SQL, SAS, R, Python, Tableau) is highly desirable. Excellent communication skills with
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