Head Of In-Country Clinical Study Operations

4 settimane fa

Lazio, Italia Merck Kgaa, Darmstadt, Germany A tempo pieno

Job Description: Head of In-Country Clinical Study Operations - Director - ItalyAs Head of In-Country Clinical Study Operations, you will:Provide leadership and 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 assigned country.Be accountable for ensuring the development of long-term relationships with clinical investigators and sites, enhancing the image and reputation of the company.Act as an interface between the company and the CRO at the country level.Serve as a point of escalation and critical interface with external partners to drive adherence to timelines/budgets and resolve functional concerns or trends contributing to delivery challenges/issues.Align on priorities at the local level with the medical and commercial organization for clinical development and life-cycle management plans/strategies.Contribute to the overall performance of the department, recommending strategies for new systems, tools, and processes to enhance efficiencies and effectiveness in the clinical study delivery process.Ensure proper conduct and support for any inspections (e.g.
from health authorities) applicable for the Local or Global department.Continuously monitor 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.As needed/assigned, fulfill the role of Clinical Site Lead and/or Clinical Research Manager, performing all related tasks/responsibilities.Who you are:Experience: 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.Independence: Ability to work independently on assigned tasks or projects of increasing complexity/sensitivity.Problem Solving: Ability to assess risk, solve problems, and make decisions.Organizational Skills: Demonstrated excellent organizational ability: time management, prioritization, and capability to handle and oversee multiple tasks simultaneously.Strategic Thinking: Strategic thinking beyond own function; familiar with and considers overall business objectives and company strategy.Leadership: Outstanding ability to lead, mentor, and manage teams; able to direct, influence, and motivate people.Matrix Organization: Ability to work and navigate effectively in a matrix organization.Adaptability: Approaches change positively; adapts behavior or work methods in response to new information, changing conditions, or unexpected obstacles.Cultural Awareness: Strong cultural awareness.Language Skills: Fluency in Italian and English (oral and written); other regional languages appreciated.Travel: Available to travel in Italy and abroad up to 30% of the time.
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