Clinical Regional Project Lead
Core
Senior clinical trial manager overseeing and coordinating project teams across designated countries to ensure consistency of Clinical Operations processes and meeting study milestones.
Role type
Senior IC clinical regional project lead
Builds
Clinical trial operations and project delivery for designated regions
Domain
Clinical research / Oncology
Deliverable
client delivery
Required skills
Clinical trial management, on-site monitoring, study planning, KPI management, site selection and initiation, regulatory submissions, safety information flow, audit/inspection management, therapeutic area training, contract negotiation
Preferred skills
GI therapeutic area experience
Technologies
MS Project
Responsibilities
Manage and coordinate project teams in designated countries; Ensure compliance with ICH-GCP and industry regulations; Develop and update project planning documents and manuals; Monitor study timelines and subject enrollment targets; Coordinate site contractual startup and budget negotiations; Supervise clinical project team members and conduct therapeutic area training; Oversee investigator and site payments; Coordinate monitoring visits and review site visit reports; Manage regulatory and Ethics Committee submissions; Oversee safety information flow.
Seniority
Senior, hands-on IC
