Head of In-Country Clinical Study Operations

12 ore fa

Rome, Italia Merck KGaA, Darmstadt, Germany A tempo pieno

As Head of In-Country Clinical Study Operations - Director - Italy 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 assigned country; you will be accountable for ensuring the development of long-term relationships with clinical investigators and sites, enhancing the image and reputation of the company and for providing an interface between the company and the CRO at the country level; you will act as a point of escalation and critical interface with our external partners at the country level to drive adherence to timelines/budgets as well as resolve functional concerns or trends contributing to delivery challenges/issues; you will be accountable for aligning on priorities at the local level with medical and commercial organization for clinical development and life-cycle management plans/strategies; you will strongly contribute to the overall performance of own department, recommending strategies for new systems, tools, and processes, enhancing efficiencies and effectiveness to improve the clinical study delivery process and elevate country performance in collaboration with other functions; 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 deficiency and providing coaching and mentoring as required in order to establish and maintain high performing teams.

As needed/assigned, fulfill 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 own function; is 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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