Project Manager, Study Start-Up (FSP) - Türkiye

FTTRK Fortrea Turkey Klinik Araştırma Limited Şirketi (Fortrea Turkey Clinical Study Limited Company; Fatih; Presencial; TRY 60.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Regulatory compliance

Budget management

Cross-functional collaboration

Project leadership

ICH/GCP knowledge

Educación

Life science degree

Healthcare certification

Nursing certification

Medical or lab technology

Descripción del empleo

Job Overview

Responsible for leading and overseeing local clinical trial operations, ensuring regulatory and financial compliance at the country level. This role plays a critical part in delivering study start-up objectives and maintaining trial integrity through collaboration with investigators, vendors, and internal stakeholders. It requires strong knowledge of local regulations, budget and contract management, and proactive issue resolution.

Key Responsibilities

• Manage country-level clinical trial submissions, approvals, and local language materials.
• Lead budget development, negotiation, and execution of Clinical Trial Research Agreements (CTRA).
• Oversee financial tracking, payment reconciliation, and forecasting in alignment with compliance standards.
• Ensure timely delivery of country-specific trial milestones and manage local vendors and contract workers.
• Collaborate cross-functionally with clinical operations, regulatory, finance, legal, and external partners.
• Maintain oversight of local processes including supplies management, archiving, and insurance documentation.
• Contribute to SOP development and ensure adherence to quality and regulatory standards.

Qualifications (Minimum Required)

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.

Required Experience

Minimum 5 or more years of clinical research experience in pharmaceutical, CRO, or healthcare settings. Good organizational and time management skills. Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred. Proven ability to manage budgets, contracts, and cross-functional collaboration under tight timelines.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.