Local Trial Manager - Sponsor Dedicated (Turkey)
iqvia · Istanbul
Job description
About the role
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department supports its client's project team in executing clinical trials. As a Local Trial Manager (full-time) in Turkey, you will work with one single client and manage clinical research projects across different therapeutic areas.
Key responsibilities
- Prepare or contribute to high-level budget estimates and detailed budget proposals in response to Requests for Service.
- Manage the overall contract, including reviewing and approving external service provider contracts, change orders and monitoring delivery.
- Act as the primary company contact for the assigned trial at country level, tracking progress against timelines and monitoring patient recruitment.
- Maintain and update trial management systems and use study tools and reports to drive study compliance.
- Take part in preparing for and conducting Health Authority inspections and internal quality assurance audits, and implement CAPA actions.
- Contribute to site-level recruitment strategy and contingency planning, and deliver competent vendor management at country level.
- Support patient understanding of the protocol and patient safety through informed consent reviews, and ensure AEs/SAEs/PQCs are reported and documented on time.
- Ensure inspection readiness by keeping data and documents complete, accurate and timely in systems such as CTMS and VTMF.
- Work with the Global Trial Lead and Clinical Project Lead on quality issues, and ensure accurate finance reporting and budget control.
- Organize IEC/HA approvals where applicable, and may negotiate site contracts and budgets; may also mentor or represent the function in process initiatives.
Required profile
- Master's or higher-level degree in life sciences preferred.
- At least 5 years of clinical research experience in the pharmaceutical industry or CRO, plus more than 1 year of local clinical trial management experience.
- Therapeutic area expertise in oncology or hematology preferred.
- Fluent Turkish at least C1 level and good command of English.
- Willingness to travel 2 to 3 times per week during audits and inspections.
Required skills
- Strong working knowledge of GCP and ICH guidelines.
- Strong IT skills in appropriate software and company systems.
- Excellent decision-making and financial management skills.
- Ability to manage study teams in a virtual environment.
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Published 5 saat önce
Expires 1 ay sonra
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iqvia
Istanbul
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