Teams at Syneos Health

Leads end-to-end clinical trial supply planning, forecasting, inventory management, packaging, labeling, distribution, vendor oversight, and risk mitigation. Collaborates with clinical, project management, procurement, and supply chain teams to align supply strategies with study needs. Manages budgets, documentation, reporting, inspection readiness, process improvement, training, and junior staff oversight. Supports business development through bid defenses and client presentations while ensuring compliance with GCP, GMP, ICH, SOPs, and regulatory requirements.

Leads statistical programming for compounds, studies, and submission projects using SAS and CDISC standards. Maintains study timelines and programming standards, reviews macros, datasets, validation outputs, and electronic submission documentation. Coordinates programming resources, supports study setup, ensures production-area organization, and mentors junior programmers. Provides expert recommendations and solutions for complex programming and regulatory compliance challenges.

Manages clinical study files, databases, regulatory documents, trial metrics, financial reports, meeting actions, document archiving, audit support, and quality activities. Maintains KPIs and customer status reports, supports sponsor communications, and may mentor Project Specialists. Requires Veeva Clinical and Excel proficiency, clinical research and oncology experience, knowledge of GCP/ICH and applicable regulations, strong organization and communication skills, and the ability to work independently while meeting multiple deadlines.