Clinical Trial Manager

3 tygodni temu

Warszawa, Mazovia, Polska CDS Fortrea Inc. Pełny etat

At CDS Fortrea Inc., we are seeking a skilled Project Manager Study-Start-Up to join our team in Poland. This full-time position is dedicated to a single sponsor and involves managing country deliverables, timelines, and results for assigned protocols.

Your Responsibilities:

  • Execute and oversee clinical trial country submissions and approvals for assigned protocols.
  • Develop local language materials, including informed consents and translations.
  • Partner with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
  • Manage country deliverables, timelines, and results for assigned protocols to meet country commitments.
  • Contribute to the development of local SOPs.
  • Collaborate with Clinical country operations, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal, and regional operations to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
  • Align country timelines for assigned protocols with Regional Operations.
  • Provide support and oversight to local vendors as applicable.
  • Assist with country and site budgets, clinical research-related payments, payment reconciliation at study close-out, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving, and retention requirements, and insurance process management.

Education, Skills, and Other Requirements:

  • University/college degree (life science preferred) or certification in a related allied health profession.
  • Previous experience in clinical research in pharmaceutical or CRO industries.
  • Previous experience in managing trials preferred.
  • Deep understanding of local regulatory environment.
  • Strong understanding of clinical trial planning, management, and metrics, as well as the ability to focus on multiple deliverables and protocols at a time.
  • Ability and skills to lead resource allocation, processes, productivity, quality, and project delivery.
  • Strong organizational skills and time management skills.
  • Excellent interpersonal skills.
  • Proficiency in written and spoken English and Polish.

We are seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. At CDS Fortrea Inc., we value collaboration, personal growth, and making a meaningful global impact.

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