Global Clinical Trial Manager — Regulatory & Country Operations

ICON Strategic Solutions; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement planning

Global Employee Assistance Programme

Life assurance

Annual leave entitlements

Résumé du poste

ICON Strategic Solutions, a sponsor-dedicated model provider, seeks a COM to lead local regulatory submissions and ICF customization for EU trials. You will collaborate with HQ and authorities to ensure timely approvals and contract delivery.

The role requires solid clinical trial management experience, advice on regulatory deliverables, and active interaction with IRB/IEC and authorities. Travel up to 25% is expected.

Qualifications

• University degree in medicine, science, or equivalent combination of education & experience.
• Demonstrated ability to drive the clinical deliverables of a study.
• Subject matter expertise in the designated therapeutic area.
• Willingness to travel as required (approximately 25%).

Responsabilités

• Oversees and tracks clinical research-related payments; oversight by finance but COM ensures compliance.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations.
• Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results to meet country commitments; ensures quality and compliance.
• Contributes to the development of local SOPs.
• Coordinates with study team members to obtain submissions, budgets, CTRAs and local milestones.
• Collaborates with Headquarter to align country timelines and provides vendor support as applicable.
• Oversees local processes, imports/exports, filing, archiving and retention; updates country information in systems.
• Ownership of local regulatory and financial compliance.

Connaissances

Clinical trial management

Regulatory affairs

Project leadership

Travel readiness

Formation

University degree in medicine, science, or equivalent combination of education & experience

Description du poste

ICON Strategic Solutions, a sponsor-dedicated model provider, seeks a COM to lead local regulatory submissions and ICF customization for EU trials. You will collaborate with HQ and authorities to ensure timely approvals and contract delivery.

The role requires solid clinical trial management experience, advice on regulatory deliverables, and active interaction with IRB/IEC and authorities. Travel up to 25% is expected.