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

Fortrea; Fatih; Hybrid; TRY 240,000 - 360,000; Full time

Job summary

Fortrea is expanding its sponsor-dedicated team in Türkiye with experienced Project Managers, Study Start-Up, to support growth. This hybrid role, based in Istanbul, focuses on leading local clinical trial operations and ensuring regulatory compliance and study start-up objectives.

Ideal candidates have 5+ years in clinical research, a life science background or related certification, and strong knowledge of ICH/GCP and local regulations.

Qualifications

• University/college degree (life science preferred) or related allied health certification.
• Minimum 5+ years of clinical research experience in pharma/CRO/healthcare.
• Knowledge of ICH Guidelines and GCP, regulatory requirements in other countries.

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.

Skills

Budget management

Contract management

Cross-functional collaboration

Regulatory knowledge

Time management

Education

Life science degree

Nursing certification

Medical or laboratory technology certification

Equivalent clinical research experience

Job description

Описание:

We are currently expanding our sponsor-dedicated team in Türkiye and are seeking experienced Project Managers, Study Start-Up, to support our continued growth and future opportunities. This hybrid position is based in Istanbul. While this role is for anticipated future opportunities in Türkiye, we would be delighted to engage with talented professionals who would like to be considered for upcoming openings. 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.

Задачи:

• 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.

Требования:

• 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.
• 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.
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