Project Manager – Study Start‑Up (Turkey)
Fortrea · Istanbul
Job description
About the role
The Project Manager, Study Start‑Up will lead local clinical trial operations in Turkey, ensuring regulatory and financial compliance. This hybrid position based in Istanbul supports the sponsor‑dedicated team and collaborates with investigators, vendors, and internal stakeholders to achieve study start‑up objectives.
Key responsibilities
- Manage country‑level clinical trial submissions, approvals and preparation of local language materials.
- Lead budget development, negotiation and execution of Clinical Trial Research Agreements (CTRA).
- Oversee financial tracking, payment reconciliation and forecasting in line 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.
Required profile
- University/college degree in life sciences or related health profession, or at least four years of relevant clinical research experience.
- Minimum five years of clinical research experience in pharmaceutical, CRO or healthcare settings.
- Strong organizational and time‑management skills with proven ability to manage budgets and contracts under tight timelines.
Required skills
- Thorough knowledge of ICH Guidelines and Good Clinical Practice (GCP).
- Working knowledge of FDA, local regulatory requirements, IRB/IEC processes.
- Experience with budget development, financial tracking and contract negotiation.
- Familiarity with investigator start‑up documents and clinical trial submission processes.
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Published 2 gün önce
Expires 1 ay sonra
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Fortrea
Istanbul
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