Head Of In-Country Clinical Study Operations

5 giorni fa


Lazio, Italia Merck A tempo pieno

Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.Your role: 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 activites 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, fullfill 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 ManagementAbility to work independently on assigned tasks or projects of increasing complexity/ sensitivityAbility to assess risk, solve problems and make decisionsDemonstrated excellent organizational ability: time management, prioritization, able to handle and oversee multiple tasks simultaneouslyStrategic thinking beyond own function; is familiar with and considers overall business objectives and company strategyOutsanding ability to lead, mentor and manage teams and to direct, influence and motivate peopleAbility to work and navigate effectively in a matrix organizationApproaches change positively; adapts behaviour or work methods in response to new information, changing conditions, or unexpected obstacleStrong cultural awarenessFluency in Italian and English (oral and written) – other regional languages appreciateAvailable to travel in Italy and abroad up to 30% of timeWhat we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress Apply now and become a part of our diverse teamJob SummaryJob number: 273171Date posted : 2024-03-25Profession: Research & Development Employment type: full-timeType: external



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