(Associate) Country Study Manager - Cell Therapy
Core
Planning and leading clinical study delivery from specifications to closeout, managing local study teams, and ensuring compliance with regulations in cell therapy trials.
Role type
Senior Clinical Study Manager (Country Level)
Builds
Clinical study operations and regulatory submissions for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / Clinical Operations
Deliverable
client delivery
Required skills
Clinical study planning and execution, local study team leadership, regulatory compliance (ICH-GCP), budget and timeline management, investigator recruitment strategy, audit and inspection coordination, risk management, document preparation (CSRs, SMAs), stakeholder communication
Preferred skills
Experience with IT systems (IMPACT, ACCORD), mentoring and competency development, process improvement
Technologies
IMPACT, ACCORD
Responsibilities
Lead local study teams and optimize performance; manage study timelines, budgets, and resources; coordinate investigator selection and recruitment strategies; prepare regulatory submissions and study documents; conduct audits and regulatory inspections; facilitate translation of study documents; ensure compliance with local policies and ICH-GCP
Seniority
Senior, hands-on IC with team leadership
