Data Quality Lead​/Data Management Lead - Oncology

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!

• 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.

• 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.

• 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.

• 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…