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Jobs at Parexel

Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Site Activation Partner II (FSP)

Job ID 69840BR Ukraine - Any Region - Home Based
The Site Activation Partner II (SAP II) 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 span within a country or multi-country depending on the geographical region and business needs.

Organizational Relationships:

Reports to the ExecuPharm (EP) assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure
Partners with Global Site and Study Operations (GSSO), Clinical Development and Operations (CD&O), Regulatory Affairs, Pharmaceutical Sciences, Medical Quality Assurance, Legal, and Drug Safety Unit

Qualifications

Education:
  • School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
  • Relevant experience in Clinical Trials environment and clinical site activation.
  • Experience working in the pharmaceutical industry/or CRO is an asset
  • Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
  • Must be fluent in Local language and in English.
  • For individuals based in Canada: Bilingualism (French, English) is an asset
  • 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
  • Experience working in a global environment
  • Experience in working in more than 1 country is an asset
  • Demonstrated knowledge and understanding of key operational elements of a clinical trial and
  • processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain
  • command of these processes
  • Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach
  • Proven 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.

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