Clinical Data Strategy Lead

Full-time onsite in North Chicago, IL 3 days/week.

The Clinical Data Strategy Lead is responsible for defining and executing the overall data strategy for clinical trials and related programs. This role ensures that clinical data is collected, managed, and delivered in a way that is compliant, high-quality, and aligned with business objectives.

• Strategic Planning:
  Develop and implement data strategies that support study design, regulatory requirements, and organizational goals.
• Governance & Standards:
  Establish and maintain data standards, governance frameworks, and compliance with CDISC, ICH, and GCP guidelines.
• Cross-Functional Leadership:
  Collaborate with clinical operations, biostatistics, data management, and technology teams to ensure seamless data flow and integration.
• Innovation & Optimization:
  Drive adoption of advanced technologies, real-world data, and process improvements to enhance data quality and accelerate timelines.

This role serves as the single point of accountability for clinical data strategy, ensuring data is not only operationally sound but also strategically valuable for decision‑making and regulatory success.

• Primary contact for all Data Science deliverables in study start-up.
• Partner with core cross‑functional study team members to ensure clinical data strategies and plans are understood and effectively incorporated into clinical plans, protocols, data strategies, data standards and plan documents during study start‑up.
• Owner of data criticality and surveillance assessment, responsible to ensure completion of tool per guidance.
• Author of and responsible for the new Integrated Data Review Plan template.
• Lead all clinical data related study start‑up meetings and go‑live communications.
• Function as a strategic advisor and critical peer to Clinical Data Program Lead, Medical, Safety, and Statistics during start‑up.
• Project Management.
• Team contributor and influencer (not necessarily management).
• Will be expected to be part of the study life early on, and participate in protocol development/defining critical values.
• Be able to push back and guide the team in the proper collection of data.

• 10 years of CDM experience.
• Medidata RAVE experience.