- Manage protocol execution and oversee the CRO, study service providers, and consultants.
- Track study milestones, metrics, and timelines, and report study status to leadership.
- Ensure trials comply with ICH GCP, regulations, the protocol, and company SOPs.
- Prepare and review clinical trial documents, including protocols, consent forms, monitoring plans, and study reports.
- Support Trial Master File management and keep clinical documentation inspection- and audit-ready.
- Identify, mitigate, and manage study risks, issues, and protocol deviations.
- Support CRO and site selection, staff training, study start-up, and site documentation.
- Assist with database lock, clinical data analyses, and preparation of clinical study reports.
- Oversee outsourced monitoring and review monitoring reports and site-related issues.
- Oversee clinical supply forecasting and support investigator meetings and study team meetings.
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