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
Requirements
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.
Benefits
Health insuranceRemote work options
Additional Information
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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!
Parexel · Remote