About Us: At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are on the lookout for a dynamic and experienced Lead in Data Quality and Management to join our oncology team. If you have a passion for clinical research, exceptional project management skills, and a strength in data management, we want to hear from you!

Who You Are:
• Educational background: BS or MS in Life Sciences, Data/Computer Science, or equivalent industry experience.
• Experience: 7+ years in clinical data management/biometrics within pharmaceutical or biotech sectors.
• Oncology experience is highly regarded, particularly in late-phase trials and women's health solid tumors.
• Strong project management proficiency along with vendor/CRO oversight.
• Excellent collaboration and outstanding communication skills, proficient in English (writing and speaking).
• Familiarity with CDISC data standards, ICH-GCP, and working in regulated environments.
• Validated project management skills, able to manage multiple priorities, demonstrate leadership in decision-making, negotiation, and influencing stakeholders.
• Experience with data analytics and visualization tools.
• Experience in leading DM study teams and a solid understanding of molecule and disease area strategies.
• Willingness to travel as necessary.

Preferred Qualifications:
• Knowledge of programming languages such as SAS, R, Python, and SQL, and familiarity with advanced analytics approaches (e.g., machine learning, AI).
• Experience with tools for analyzing large data sources and producing interactive outputs (e.g., Tableau, Shiny).
• Background in SDTM implementation and understanding of reproducible research practices.
• Health professional credentials (e.g., BSN, RN, Pharm D) are desirable.

What You Will Be Doing: As the Data Quality Lead, your responsibilities will include:
• Developing and implementing risk management strategies to keep studies on track.
• Engaging with stakeholders to understand their needs and ensuring they are informed of key decisions and deliverables.
• Partnering with teams for vendor selection and management, ensuring compliance with data standards.
• Advising on best practices for data collection and proposing innovative solutions.
• Using surveillance tools to monitor data quality and identify potential issues.
• Organizing and integrating data from diverse sources, adhering to FAIR principles.
• Managing cross-functional Data Management Leadership and coordinating with ancillary systems.
• Defining mitigations for project risks and driving resolutions with stakeholders.
• Reviewing project financials and ensuring alignment with budgets.
• Providing insightful feedback on company initiatives that impact Data Management.
• Overseeing training compliance and addressing development needs within the team.

Compensation: Base pay range is $99,000 to $180,000 yearly, with additional performance-based bonuses and excellent benefits including paid time off, 401k matching, and health insurance.

EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.