Data Management Lead

Job Title: Data Management Lead (Medical Affairs)

Location: Fully Remote (US based) Must be able to accommodate West Coast 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 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 in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
• Medical affairs experience (Phase IIIB - IV trials experience)
• 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 influencing.
• 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:

• Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
• Proficient 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).
• 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, with contributions to open-source packages, libraries, or functions.

What you will be doing:

Responsibilities will include:

• Develop risk management strategies and proactively manage timelWhat ines 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 functional input, considering the impact on Data Management and Parexel as a whole.
• Support other functions by providing meaningful feedback on initiatives.
• Ensure Parexel-requested information entered into management systems is accurate and regularly updated.

Training:

• Maintain training compliance as per job roles assigned, including on-the-job training.
• Deliver project-specific training to internal Data Management teams.
• Address training needs based on identified development goals.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.