Sr. Site Manager
IQVIA Argentina
Ciudad de México, Ciudad de México, México
hace 3 días
source : JobLeads

Estamos buscando el candidato adecuado para cubrir este puesto en una empresa apasionante.

PURPOSE

  • Responsible for independently and effectively managing sites to drive their performance throughout the lifecycle of the study, from site identification to study closure.
  • Act as single point of contact with sites and ensure compliance with all applicable regulations, Good Clinical Practices (GCP), and standard operating procedures (SOPs).

    RESPONSIBILITIES

  • Perform site identification and selection, start-up, initiation, monitoring and close out in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions
  • Act as single point of contact with study sites, ensuring successful collaboration and meeting study expectations and milestones
  • Prepare ethics submissions and negotiate site contracts and budgets
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
  • Conducts continuous monitoring activities (both onsite and remote)
  • Identifies issues at sites; resolves issues and escalates as appropriate
  • Execute assigned work efficiently and adhere to project timelines and financial goals; review site performance metrics and make recommendations accordingly
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation
  • May conduct primary data collection at sites
  • May aid less experienced staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
  • May act as point of contact for other staff on project

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Strong knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Ability to anticipate potential issues and take appropriate actions with and / or without supervision
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPointAdvanced
  • communication skills and ability to influence others
  • Ability to manage multiple priorities and manage time efficiently
  • Ability to travel domestically (possibly internationally) as needed to study sites and meetings
  • Occasional overnight travel may be required
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree, preferably in life science, and >
  • 4 years of site monitoring and management experience; or equivalent combination of education, training and experience

    PHYSICAL REQUIREMENTS

  • Extensive use of telephone and face to face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
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