The Site Activation Partner I (SAP I) is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.

SKILLS:

• Knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details
• Understand the quality expectations and emphasis on right first time
• Compliance with all applicable company, regulatory and country requirements
• Attention to detail evident in a disciplined approach
• Ability to work independently and also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations
• Ability to use and learn systems, and to use independently
  o Microsoft Suite
  o Clinical Trial Management Systems (CTMS)
  o Electronic Trial Master File
  o Electronic Investigator Site File (e.g. Florence)
  o Document exchange portals
  o Shared Investigator Platform

o Ethics, National Networks and Governing Bodies Portals and platforms (as needed)

• Flexible and adapt to off working hours in a global environment (when applicable)
• Able to travel as needed, including some international travel possible

KNOWLEDGE AND EXPERIENCE:

• Experience working in the pharmaceutical industry/or CRO in study site activation preferred
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• Must be fluent in local language and in English. Multilanguage capability is preferred
• Individuals based in Canada: Bilingualism (French, English) is preferred
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems

EDUCATION:

• School diploma or certificate with equivalent combination of education, training and experience or
• Bachelor of Science or Bachelor of Arts or equivalent
• Education in life sciences discipline is preferred
• Minimum 2 years relevant experience in clinical site management

Please refer the Job description for details