Provide daily oversight for international trials, delivering data on time and budget.
Develop and execute operational plans for oncology trials.
Collaborate with cross-functional teams to ensure rapid, high-quality data delivery.
Manage trial start-up with Site Engagement for site selection and feasibility.
Ensure regulatory compliance with ICH-GCP and FDA throughout the trial lifecycle.
Lead creation and maintenance of study files (TMF) and site files.

🎯 Requirements

Bachelor's or higher degree in a relevant scientific discipline.
5+ years in Clinical Operations; oncology trial exp preferred.
Strong knowledge of ICH-GCP and FDA regulations in oncology.
Proven track record managing trials from start-up to closeout.
Strong project management skills: prioritization, resource allocation, timelines.
Excellent communication with stakeholders and site personnel.

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