Manager, Clinical Operations, Early Development, Oncology
Johnson & Johnson
Manager leading clinical operations for early-stage oncology trials (Phase 0-IIa) across multiple regions. Oversees trial execution, team management, resource allocation, regulatory compliance, and process improvements while directing clinical and site management staff.
Responsibilities
- Direct line management of trial managers, site managers, and clinical trial assistants
- Oversee execution and inspection-readiness of Phase 0-IIa trials across therapeutic areas
- Evaluate resource needs and support flexible staffing model for portfolio assignments
- Ensure compliance with ICH-GCP, SOPs, and local regulatory requirements
- Develop strategy for regional ED&CP organization and drive process improvements
Requirements
- Line management experience with clinical trial or healthcare operations teams
- Knowledge of ICH-GCP, clinical trial SOPs, and regulatory requirements
- Experience managing early development or clinical pharmacology trials
- Demonstrated ability to manage budgets and allocate resources effectively
- Strong stakeholder management skills across ethics committees and health authorities
- Leadership competencies aligned with organizational values and change management
Vacancy posted 3 days ago
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