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SAS II

Full-Time Tokyo, Japan
Health & Biotech
Health & Biotech
06 June 2025
Description
  • Manage and execute the site identification process in accordance with regulations, SOPs, and project requirements, ensuring timely and accurate completion of all tasks
  • Complete and negotiate site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, ensuring compliance with legal and regulatory requirements
  • Maintain, review, and report on site performance metrics, identifying areas for improvement and implementing corrective actions as needed
  • Serve as the primary point of contact for investigative sites, providing support and guidance throughout the site identification process
  • Track the completion of site identification for sites, ensuring all necessary documentation is collected and maintained in accordance with SOPs and project requirements
  • Contribute to the design, implementation, and delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education and experience
  • Utilize practical knowledge of the professional area to manage defined components of projects or processes within area of responsibility, ensuring alignment with overall project goals and objectives
  • Direct the work of lower level professionals or manage processes and programs, providing guidance and support to ensure successful completion of tasks
  • Collaborate with cross-functional teams to ensure seamless integration of site identification activities with other project components
  • Stay current with industry trends and best practices, incorporating new knowledge and skills into daily work to enhance overall performance
Qualifications
  • Bachelor's degree in a relevant field or equivalent experience
  • Minimum of 3 years of experience in site start-up or site identification
  • Strong understanding of regulations, SOPs, and project requirements related to site identification
  • Excellent negotiation and communication skills
  • Ability to manage multiple tasks and projects simultaneously
  • Detail-oriented with strong organizational skills

Certifications

  • Certification in clinical research or related field preferred
  • Training in Good Clinical Practice (GCP) and other relevant regulations

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