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  • Posted: Sep 20, 2017
    Deadline: Not specified
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    Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with i...
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    Country Monitoring Head

    Job description

    Accountable for all country clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. Responsible for implementing the Trial Monitoring archetype and Regional/Cluster/Country strategy, while delivering to Country budget and productivity targets in line with Trial Monitoring and local business objectives. Operationally responsible for building a high performing team culture and ensuring standardization across Development Units - including talent development, performance management and established monitoring procedures in accordance to GCP, ICH and local regulations. The Country Head is responsible for monitoring integration within Country, CSO and Medical to ensure alignment on portfolio strategy, prioritization and performance to aligned objectives for GDD trial delivery. Delivers to defined Trial Monitoring and Regional monitoring strategies to deliver Country business and trial strategy objectives in close collaboration with Region Head or Cluster Head of Trial Monitoring and Country CSO and Medical Director Aligns Country monitoring objectives to Region Head or Cluster Trial Monitoring and country CSO/Medical Director Identifies and implements innovative practices and patient engagement strategies in collaboration with Country CSO and Medical Director within the Country to advance clinical trial planning, execution and quality Manages Country feasibility process (per Trial Monitoring Regional strategy) to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV trials) Drives collaborative engagement model with Regional Operations Manager (ROM) and Trial Operations Management (TOM) to ensure Country participation in GDD trials is aligned with country and Trial Monitoring Regional strategy Ensures Country trial site selection, activation, enrolment, resource allocation, timelines and budget commitments are delivered per established trial objectives Builds and maintains effective site relationship management to ensure site performance to trial commitments and delivery of quality monitoring Actively monitors quality KQI’s in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements

    Minimum requirements

    • A degree in scientific or health discipline required and advanced degree preferable.
    • Fluency in English (oral and written). Thorough knowledge of the drug development process, execution and monitoring of interventional and observational studies in all phases of development, especially Phase II to IV.
    • Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP), health authorities (FDA, EMEA), local/ national Health Authorities regulations and Novartis standards Strong understanding of general medical and clinical research practice in countries under responsibility as well as established contacts within the medical community preferable
    • Proven leadership capabilities and ability to work with and oversee diverse teams preferred.
    • Previous people management/direct line management experience preferred
    • Ability to manage a wide variety of external and internal stakeholders, including study site personnel.
    • Strong organisational, interpersonal and analytical skills, problem solving ability.

    Method of Application

    Interested and qualified? Go to Novartis on www.linkedin.com to apply

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