Senior Clinical Trial Manager Turkey

Senior Clinical Trial Manager - sponsor dedicated , 1 year contract, remote

Main Purpose

The Senior Clinical Trial Manager (Sr. CTM) is responsible for leading site management activities from study start‑up through close‑out across assigned clinical trials. The role ensures trial conduct is compliant with protocols, ICH‑GCP, regulatory requirements, and internal procedures. The Sr. CTM will oversee CROs, collaborate with cross‑functional teams, and support efficient study execution, including site selection, initiation, monitoring oversight, and issue resolution.

Key Responsibilities

• Manage day‑to‑day oversight of clinical trial sites and CROs to ensure timely recruitment, high‑quality data, and adherence to protocol and GCP.
• Lead study start‑up activities: site feasibility, selection, contracts/budgets, IRB/EC submissions, and essential document collection.
• Conduct oversight visits (including pharmacy visits) and review CRA monitoring reports to ensure site and CRO compliance.
• Monitor site performance metrics, protocol deviations, data quality, and operational issues; escalate and resolve risks proactively.
• Collaborate with the Clinical Project Manager, Medical Monitor, Regulatory, Clinical Supplies, QA, and vendors to ensure study timelines and deliverables are met.
• Review and contribute to study documents, including protocols, ICFs, monitoring plans, recruitment strategies, manuals, and training materials.
• Provide study status updates to internal teams and support training delivery as required.
• Support implementation of patient recruitment and retention plans.
• Serve as subject matter expert for assigned studies, responding to operational and protocol-related queries from CROs, vendors, and sites.

Qualifications

Essential

• Bachelor’s degree in life sciences, pharmacy, or related field.
• 8+ years of clinical operations experience within biotech, pharma, or CRO.
• Working knowledge of GCP/ICH and global regulatory requirements.
• Hands‑on experience with site start‑up and site initiation.
• Strong relationship‑building skills with sites, investigators, and vendors.
• Ability to identify risks, drive issue resolution, and work independently.
• Experience delivering clear presentations and written communications.
• Oncology and/or immunotherapy experience.
• Minimum 2 years of on‑site monitoring (CRA) experience.