Manager, Evidence Generation Study Design & Execution Lead
Core
Manages non-site-based study operations for evidence generation, including intake, documentation, close-out, and contracting support to enable Global Evidence Generation teams to focus on strategy.
Role type
Manager, Evidence Generation Study Design & Execution Lead
Builds
Evidence generation workflows, study documentation packages, and contracting materials for Global Evidence Generation teams.
Domain
Biopharmaceutical / Life Sciences / Clinical Operations
Required skills
Study operations management, Intake and triage, Documentation tracking, Study close-out procedures, Cross-functional coordination, Contracting support, Vendor artifact management, Audit-ready repository maintenance, Process improvement, Automation tool usage
Preferred skills
Biopharmaceutical industry experience, Evidence generation operations, HEOR operations, Clinical operations, iEnvision Research Module, Veeva Vault
Technologies
iEnvision Research Module, Veeva Vault, Document repositories, Procurement systems
Responsibilities
Receive and log evidence generation and contracting requests; Conduct completeness checks and route requests; Coordinate cross-functional protocol review logistics; Maintain study documentation checklists and status trackers; Prepare study status summaries for governance review; Apply standard close-out procedures and store final packages; Support FMV documentation and archival; Prepare internal contracting initiation packages; Coordinate Legal review and track contracting milestones; Store vendor artifacts with correct metadata; Identify process gaps and support template improvements.
Seniority
Manager, hands-on IC
