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Head of Clinical Study Operations Director

2 mesi fa

Roma, Lazio, Italia Https:Www.Energyjobline.ComSitemap A tempo pieno
Job Title:

Head of Clinical Study Operations Director - Director - Italy

The Head of Clinical Study Operations Director will provide leadership, drive performance, and steer strategic direction for all activities and personnel (including Functional Services Provider (FSP) team members) for the assigned country.

This role will be accountable for developing long-term relationships with clinical investigators and sites, enhancing the company's image and reputation.

The Head of Clinical Study Operations Director will serve as the interface between the company and the CRO at the country level.

Key responsibilities include acting as a point of escalation and critical interface with external partners to drive adherence to timelines and budgets, and resolve functional concerns contributing to delivery challenges.

This role will align priorities at the local level with medical and commercial organizations for clinical development and life-cycle management plans/strategies.

The Head of Clinical Study Operations Director will contribute to the overall performance of the department by recommending strategies for new systems, tools, and processes to enhance efficiencies and effectiveness.

This role will ensure proper conduct and support for any inspections (e.g., from health authorities) applicable to the local or global department.

The Head of Clinical Study Operations Director will continuously monitor performance of assigned staff against applicable practices and expectations, addressing deficiencies and providing coaching and mentoring as required to establish high-performing teams.

As needed/assigned, this role will fulfill the role of Clinical Site Lead and/or Clinical Research Manager, performing all related tasks and responsibilities.

Requirements:

  • Substantial (10+ years) professional experience in Clinical Research in biotech, pharma, or CRO, including experience in Clinical Trial Management and managing Clinical Monitoring/Site Management.
  • Ability to work independently on assigned tasks or projects of increasing complexity/sensitivity.
  • Ability to assess risk, solve problems, and make decisions.
  • Demonstrated excellent organizational ability: time management, prioritization, and handling multiple tasks simultaneously.
  • Strategic thinking with familiarity of overall business objectives and company strategy.
  • Outstanding ability to lead, mentor, and manage teams, influencing and motivating people.
  • Ability to navigate effectively in a matrix organization.
  • Positive approach to change; adapts behavior or work methods in response to new information or unexpected obstacles.
  • Strong cultural awareness.
  • Fluency in Italian and English (oral and written); knowledge of other regional languages is appreciated.
  • Available to travel in Italy and abroad up to 30% of the time.