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Project Manager

4 tygodni temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat
About the Role

We are seeking a highly experienced Project Manager to lead our clinical trials team at Innovaderm Research. As a Project Manager, you will be responsible for overseeing the planning, execution, and delivery of clinical trials across multiple sites and regions.

Your primary focus will be on ensuring the successful completion of clinical trials, while maintaining a strong focus on quality, risk management, and budget control.

You will work closely with our cross-functional teams, including regulatory affairs, data management, clinical monitoring, and biostatistics, to ensure that all tasks and deliverables are completed on time, according to plans, and according to applicable standards.

Key Responsibilities
  • Lead the planning and execution of clinical trials, including study start-up, regulatory submission, and clinical monitoring.
  • Develop and manage project budgets, timelines, and resource allocation.
  • Ensure compliance with GCP, ICH, and local country regulations.
  • Collaborate with vendors and internal teams to ensure seamless project execution.
  • Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.
Requirements
  • At least 5 years of industry experience, including a minimum of 3 years leading multi-center clinical trials (phase II-III).
  • Experience leading concurrent multi-centered clinical trials involving multiple countries/regions is an asset.
  • Excellent knowledge of GCP and ICH standards, FDA and local country regulations.
  • Fluency in English with excellent oral and written skills, required.
  • Additional languages represent an asset.