Head of In-Country Clinical Study Operations

4 settimane fa

Rome, Italia https:www.energyjobline.comsitemap.xml A tempo pieno
Head of In-Country Clinical Study Operations - Director - Italy

As the Head of In-Country Clinical Study Operations, you will provide leadership, drive performance, steer strategic direction, and ensure strong clinical operational oversight for all activities and personnel (inclusive of Functional Services Provider (FSP) team members) for the assigned country. You will be accountable for:

  1. Ensuring the development of long-term relationships with clinical investigators and sites.
  2. Enhancing the image and reputation of the company.
  3. Providing an interface between the company and the CRO at the country level.
  4. Acting as a point of escalation and critical interface with our external partners at the country level.
  5. Driving adherence to timelines/budgets and resolving functional concerns or trends contributing to delivery challenges/issues.
  6. Aligning on priorities at the local level with medical and commercial organizations for clinical development and life-cycle management plans/strategies.
  7. Contributing to the overall performance of your department, recommending strategies for new systems, tools, and processes to enhance efficiencies and effectiveness.
  8. Ensuring proper conduct and support for any inspections (e.g., from Health authorities) applicable for the Local or Global department.
  9. Continuously monitoring the performance of assigned staff against applicable practices and expectations, addressing any deficiencies and providing coaching and mentoring as required to establish and maintain high-performing teams.
  10. As needed, fulfilling the role of Clinical Site Lead and/or Clinical Research Manager performing all related tasks/responsibilities.

Who you are:

  • Substantial (10+ years) professional experience in Clinical Research in biotech, pharma, or CRO, including experience in Clinical Trial Management and working in or 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, able to handle and oversee multiple tasks simultaneously.
  • Strategic thinking beyond your own function; familiar with and considers overall business objectives and company strategy.
  • Outstanding ability to lead, mentor, and manage teams and to direct, influence, and motivate people.
  • Ability to work and navigate effectively in a matrix organization.
  • Approaches change positively; adapts behavior or work methods in response to new information, changing conditions, or unexpected obstacles.
  • Strong cultural awareness.
  • Fluency in Italian and English (oral and written) – other regional languages appreciated.
  • Available to travel in Italy and abroad up to 30% of the time.
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