Lead Clinical Research Associate
Core
Lead a clinical research team to oversee study execution, ensure compliance, and drive trial activities at a country or regional level.
Role type
Senior Lead Clinical Research Associate (Regional/Country Level)
Builds
Clinical trials (Phase II/III) across various therapeutic areas
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical site monitoring, project management, data integrity management, regulatory compliance, team leadership, risk management, supply chain management, audit coordination, training delivery
Preferred skills
Oncology, Cell Therapy (CAR-T, Gene Therapy), Nuclear Medicine, GI disorders
Technologies
MS Office
Responsibilities
Monitor project timelines, patient enrollment, and data cleaning; review monitoring visit reports; lead project team calls and provide status updates; provide training and prepare materials for the project team; supervise source data verification and data queries; manage clinical study supplies; review essential study documents and ISF/TMF; ensure data integrity and compliance; coordinate safety information flow and protocol deviations; manage site contracting and payments; conduct audit preparation visits; oversee CAPA development; mentor newly promoted Lead CRAs; deliver presentations at Investigator Meetings.
Seniority
Senior, hands-on IC with leadership responsibilities
