Remote Senior Clinical Trial Manager - Study Delivery
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Benefits offered by this job
Job summary
ICON seeks a Senior Clinical Trial Manager to lead country-level clinical study delivery, ensuring execution per protocol, ICH GCP, and regulatory requirements. You will oversee start-up, site activation, budgets, and TMF management, while guiding local study teams toward inspection readiness.
You will collaborate with global teams to drive patient recruitment, risk mitigation, and timely study delivery, with travel up to 25% as needed.
Qualifications
- Lead country-level clinical study delivery and ensure protocol compliance.
- Strong knowledge of ICH GCP and regulatory requirements.
- Experience leading cross-functional study teams and managing budgets.
Responsibilities
- Lead and coordinate Local Study Teams (CRAs and study staff) to meet timelines and quality.
- Oversee country-level start-up activities: feasibility, site activation, regulatory submissions.
- Monitor study progress, identify risks, and implement mitigations.
- Provide guidance to CRAs to ensure protocol and regulatory compliance.
- Manage budgets, contracts, site payments, and TMF/eTMF oversight.
- Support inspection readiness through audits and regulatory inspections.
- Collaborate with global teams to support patient recruitment and delivery.
Skills
Education
Job description
ICON seeks a Senior Clinical Trial Manager to lead country-level clinical study delivery, ensuring execution per protocol, ICH GCP, and regulatory requirements. You will oversee start-up, site activation, budgets, and TMF management, while guiding local study teams toward inspection readiness.
You will collaborate with global teams to drive patient recruitment, risk mitigation, and timely study delivery, with travel up to 25% as needed.
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