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Local Trial Manager - Sponsor Dedicated (Turkey)

iqvia · Istanbul

New
Senior 🇬🇧 English
GCP ICH CTMS VTMF

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.

Questions fréquentes

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Source : ats:workday

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Published 11 saat önce

Expires 1 ay sonra

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iqvia

Istanbul