Clinical Trial Project Manager - Regulatory & Budget Lead

FTTRK Fortrea Turkey Klinik Araştırma Limited Şirketi (Fortrea Turkey Clinical Study Limited Company; Fatih; In loco; TRY 60.000 - 120.000; Tempo pieno

Descrizione del lavoro

Fortrea Turkey Clinical Study Limited Company is seeking an experienced professional to lead and oversee local clinical trial operations, ensuring regulatory and financial compliance at the country level. You will collaborate with investigators, vendors, and internal partners to deliver study start-up objectives and maintain trial integrity.

You will manage country-level submissions, budgets, CTRA, and financial forecasting, while ensuring adherence to ICH/GCP guidelines and local regulations.

Competenze

• Minimum 5+ years of clinical research or healthcare experience.
• Strong knowledge of ICH/GCP and regulatory guidelines.
• Budget, contracts, and cross-functional collaboration skills.

Mansioni

• Manage country-level submissions, approvals, and local language materials.
• Lead budget development, negotiation, and execution of CTRA.
• Oversee financial tracking, payment reconciliation, and forecasting.
• Ensure timely delivery of country-specific trial milestones and vendor management.
• Collaborate cross-functionally with clinical operations, regulatory, finance, legal, and partners.
• Maintain oversight of local processes including supplies, archiving, and insurance documentation.
• Contribute to SOP development and ensure adherence to quality standards.

Conoscenze

Regulatory compliance

Budget management

Cross-functional collaboration

Project leadership

ICH/GCP knowledge

Formazione

Life science degree

Healthcare certification

Nursing certification

Medical or lab technology

Descrizione del lavoro

Fortrea Turkey Clinical Study Limited Company is seeking an experienced professional to lead and oversee local clinical trial operations, ensuring regulatory and financial compliance at the country level. You will collaborate with investigators, vendors, and internal partners to deliver study start-up objectives and maintain trial integrity.

You will manage country-level submissions, budgets, CTRA, and financial forecasting, while ensuring adherence to ICH/GCP guidelines and local regulations.