This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Data Quality Lead / Data Management Lead - Oncology based in United States.
This role plays a pivotal part in ensuring the integrity, consistency, and scientific reliability of clinical trial data across complex, late-phase oncology studies. You will act as a strategic leader within data management, overseeing end-to-end data quality activities from study start-up through database lock. The position combines hands-on oversight of data systems with high-level stakeholder engagement across clinical, biometrics, and vendor teams. You will help shape data strategies that directly support regulatory submissions and evidence generation. Operating in a remote, cross-functional environment, you will guide study teams through data challenges in a fast-paced, highly regulated setting. This role is ideal for someone who thrives at the intersection of science, data, and operational execution in oncology research.
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 the ability to influence, mentor, and guide multidisciplinary teams.
Benefits:
- Competitive base salary ranging from $99,000 to $180,000 annually depending on experience and location
- Eligibility for annual performance-based bonus programs (for qualifying roles)
- Comprehensive health benefits including medical, dental, and vision coverage
- 401(k) retirement savings plan with company match
- Paid time off and holidays, supporting work-life balance
- Life insurance and additional employee protection programs
- Opportunities for professional development, training, and career progression
- Flexible remote working arrangement with alignment to Pacific Time Zone hours