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.