Sr. Trial Manager, Early Development, Oncology
$92k - $148.35kJohnson & Johnson
Senior Trial Manager responsible for overseeing early-stage oncology clinical trials at country level. Manages protocol compliance, regulatory requirements, site coordination, and trial data quality from startup through closeout, while mentoring staff and contributing to process improvements.
Responsibilities
- Oversee assigned protocol operations from initiation through database lock and closeout
- Lead local site selection, feasibility assessments, and pre-trial activities with study team
- Develop and maintain local trial procedures, recruitment plans, and risk management strategies
- Monitor trial progress, ensure SAE/SUSAR reporting compliance, and implement corrective actions
- Mentor Site Managers and Clinical Trial Assistants; contribute to process improvement initiatives
Requirements
- Expertise in clinical trial management and GCP compliance
- Experience managing early development and Phase I/II oncology studies
- Knowledge of regulatory requirements and healthcare compliance frameworks
- Demonstrated ability to lead cross-functional teams and manage budgets
- Strong project management and risk mitigation skills
- Proficiency with clinical trial management systems and reporting tools
Vacancy posted 4 days ago
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