Clinical Operations Manager

1 giorno fa


Roma, Lazio, Italia BeiGene, Ltd. A tempo pieno
Job Description

Job Title: Clinical Operations Manager - Italy

Job Summary: We are seeking a highly skilled Clinical Operations Manager to join our team in Italy. The successful candidate will be responsible for managing study start-up and trial monitoring staff, as well as collaborating with the Regional Clinical Operations Manager to ensure study timelines are adhered to and quality standards are maintained.

Key Responsibilities:

  • Manage study start-up and trial monitoring staff in accordance with BeiGene's policies and applicable regulations in Italy
  • Participate in the selection for hiring new employees and ensure proper onboarding and training
  • Manage the quality of assigned staff's clinical work through regular review and evaluation
  • Provide country-specific study start-up expertise to study start-up team leads and project teams
  • Collaborate with Regional Clinical Operations Manager and clinical study sites to achieve timely and complete IRB/EC submissions, ensure TMF completeness, and ensure successful delivery of country site commitments

Requirements:

  • Bachelor's degree (or equivalent) or higher in a scientific, medical, or healthcare discipline
  • Minimum of 5-7 years progressive experience in clinical operations within the biotech/pharmaceutical sector within Italy
  • Prior clinical trial experience, including experience in a management/leadership capacity (like CRA lead)
  • Experience in oncology is highly recommended
  • Ability to work independently and effectively handle multiple priorities in a fast-paced environment
  • Excellent interpersonal skills, strong organizational skills
  • Fluent in English and French (writing and speaking)
  • Computer skills in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook
  • Travel: up to 30-40%


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