Associate Clinical Project Manager

6 dni temu


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

We are seeking an experienced Clinical Project Manager Associate to join our team at Innovaderm Research. In this role, you will be responsible for ensuring the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects.

Key Responsibilities
  • Project Management: Ensure compliance with the study budget, project scope, and timelines, and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory, and study-specific requirements.
  • Communication: Serve as primary contact for the Sponsor, vendors, and internal team throughout the study, coordinate tasks and deadlines between different departments involved in the project, and interact with vendor management to ensure vendor supplies and services are coordinated for with site activation timelines.
  • Project Coordination: Oversee project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities amongst team members, assist with managing the needs and expectations of the Sponsor and other internal and external project stakeholders, and ensure that all team members are adequately trained on the project.
  • Quality Assurance: Manage the quality of assigned work and deliverables, reconcile study trackers, and assist with analyzing discrepancies between planned and actual results and participating in the development and implementation of corrective actions as needed.
Requirements
  • Education: B.Sc. in a related field of study to clinical research.
  • Experience: Minimum 5 years of relevant industry experience in the pharmaceutical, biotechnology, or CRO industry, with at least 2 years of experience coordinating activities related to clinical trial management.
  • Skills: Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations, excellent knowledge of Microsoft Office suite, excellent oral and written skills in English, ability to work in a team environment and establish good relationships with colleagues and sponsors, and good problem-solving abilities.


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