Clinical Trial Manager

2 tygodni temu

Warszawa, Mazovia, Polska CDS Fortrea Inc. Pełny etat

As a leading global contract research organization (CRO), CDS Fortrea Inc. provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

We are seeking a highly motivated and experienced Project Manager Study-Start-Up (COM) to join our team in Poland. In this position, you will be fully dedicated to a single sponsor and will be responsible for the execution and oversight of clinical trial country submissions and approvals for assigned protocols.

Your responsibilities:

  • Development of local language materials including local language Informed Consents and translations
  • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols
  • Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments
  • Contributes to the development of local SOPs
  • Works in close collaboration internally with Clinical country operations, Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
  • Collaborates closely with Regional Operations to align country timelines for assigned protocols
  • Provides support and oversight to local vendors as applicable
  • Financial duties including assistance with the ownership of country and site budgets
  • Oversight and tracking of clinical research-related payments
  • Payment reconciliation at study close-out
  • Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
  • Enters and updates country information in clinical, regulatory, safety and finance systems

Education, Skills and Other Requirements:

  • University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
  • 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 is important as well as the ability to focus on multiple deliverables and protocols at a time
  • Ability and skills to lead resource allocation, processes (and controls), productivity, quality and project delivery
  • Strong organizational skills and time management skills
  • Excellent interpersonal skills
  • Proficiency in written and spoken English and Polish

CDS Fortrea Inc. is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

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