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Clinical Trial Manager

Organization
Agilent
Job Location
6392 Via Real, Carpinteria
Carpinteria, CA 93013
United States
Job Description

Job DescriptionAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Agilent's Companion Diagnostics Business (CDx) partners closely with leading pharmaceutical companies to develop, manufacture and commercialize in vitro diagnostic devices, which are a critical part of precision medicine. We are looking for a Clinical Trial Manager to join our Clinical Affairs team. In this role the primary responsibility is to Plan, coordinate and handle the day-to-day running of clinical studies for cancer in vitro diagnostics (IVDs) to support regulatory applications and scientific marketing activities. These activities will be conducted in collaboration with Research & Development, Quality Assurance, Regulatory Affairs, and other partners.

  • Leads Clinical Trials and/or Clinical Affairs and/or medical employees and/or other Clinical managers
  • Guides employees responsible for overall clinical study management, including planning, communication, coordination and practical tasks for the studies
  • Ensures quality, consistency and mentorship to the employee team on clinical and/or medical operations and associated core deliverables including resource planning and coordination, monitoring, initiation/training, lab site, and Contract Research
  • Develops contingency plans for clinical studies and acts as a cross-functional liaison to ensure study plan aligns with business strategies
  • Evaluates processes and procedures, and implements new and vital improvements
  • May develop and lead clinical budgets
  • May support companion diagnostics partner programs and build up an external network
  • May participate in the business development processes to address unmet medical and clinical needs, translating those unmet needs into high-value product opportunities and business models
  • Collaborate closely with relevant health care professionals and organizations to explore unmet medical needs and product opportunities
  • Selects develops and evaluates personnel to ensure efficient clinical and/or medical operations
  • Ensures compliance with good clinical practices and regulatory guidelines
  • Prepares, revises and maintains procedures for the conduct of studies
Requirements

Qualifications

  • Bachelor's degree or equivalent education in biological or biochemical sciences or related field
  • A minimum of 3 years of Clinical Trial Management experience for diagnostic, medical device, or pharmaceutical products
  • A solid understanding of project management and familiarity with project management tools
  • Experience in CRO/vendor management and contracting
  • Understand the requirements of various controlling bodies and frameworks
  • Experience in working in parallel project teams

Preferred Qualifications:

  • Advanced degree preferred or Bachelor´s degree with equivalent job experiences
  • Clinical certification in biological or biochemical sciences or related field
  • Experience in pathology and/or oncology
  • Experience in vitro diagnostics
  • Ability to travel globally post COIVD

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