Teams at Syneos Health

Manages Clinical Data Science staff, client relationships, project delivery, budgets, quality, utilization, training, and regulatory readiness across clinical studies. Oversees clinical data science activities from project launch through closeout, supports audits and CAPAs, monitors data quality and risk, mentors team members, contributes to business development, and helps develop tools, SOPs, and processes for clinical data management.

Reviews and evaluates clinical trial data within oncology studies, supporting data quality, consistency, and drug development objectives. Collaborates with clinical solutions and study teams to identify issues, apply therapeutic expertise, and help deliver reliable outcomes for life sciences customers.

Lead regulatory CMC lifecycle management strategies and submissions for small-molecule pharmaceutical programs across the US, Canada, and EU. Review CMC sections of regulatory submissions and agency interactions, develop global regulatory strategies, and serve as the primary regulatory CMC contact for assigned products. Collaborate cross-functionally while applying FDA, EMA, Health Canada, ICH, and cGMP knowledge.