**Job Title: Data Quality Lead / Data Management Lead - Oncology** **Location: USA -Remote- with the ability to work Pacific Standard Time Zone hours.** **About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Quality Lead/Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you! **Who You Are:** **Required:** + BS or MS in Life Sciences, Data/Computer Science, or equivalent industry experience. + 7+ years' experience clinical data management/biometrics in pharmaceutical/biotech clinical + Medical affairs experience is a plus, but not necessary. + Experience in Phase IIIB-IV trials is a plus. + Oncology experience (Solid Tumor) + Late-phase oncology experience, ideally in women's health solid tumors, is a plus. + Strong project management experience and vendor/CRO oversight. + Demonstrated collaboration and superb communication skills, both written and oral proficiency in English required. + Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity. + Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and placing influence. + Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques. + Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or real-world data, with a good understanding of molecule and disease area strategies and the healthcare environment. + Ownership and accountability relative to key accountabilities in the job description. + Ability to travel as required. + Written and oral fluency in English. **Preferred:** + Understanding data structure and programming languages such as SAS, R, Python, and SQL, and advanced analytics approaches (e.g., machine learning, AI). + Understanding and/or proficiency with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau). + Understanding and/or experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming. + BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, along with contributions to open-source packages, libraries, or functions. **What you will be doing:** **Responsibilities will include:** + Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects. + Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones. + Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models. + Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data. + Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results. + Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis. **Cross-functional Data Management Leadership:** + Manage and coordinate the integration and utilization of all ancillary systems. + Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan. + Review and analyze metrics to derive meaningful summaries of study health and trends. + Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators. + Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs. **Project Financial and Resource Management:** + Ensure appropriate project-level resourcing of staff and staff assignments. + Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand. + Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope. **Company Initiatives:** + Provide Data Management