Study Start-Up Specialist

Added
20 days ago
Type
Full time
Salary
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Related skills

document management regulatory affairs clinical research clinical trial management risk assessment

📋 Description

  • Lead start-up and maintenance activities for assigned studies and sites, ensuring timely delivery
  • Develop country and site activation plans, prioritize activities, and support risk assessment and
  • Identify and communicate issues that may affect delivery and recommend solutions
  • Participate in study start-up meetings and provide updates on assigned studies and sites
  • Collect, review, and maintain essential documents in accordance with applicable standards
  • Prepare and submit ethics committee and other local document packages, including informed consent

🎯 Requirements

  • Fluency in Dutch language required
  • Bachelor’s degree or equivalent qualification; a health-related degree in medicine, science
  • At least 1–2 years of clinical research experience
  • Experience working with remote or virtual teams
  • Working knowledge of ICH Good Clinical Practice and the applicable country’s regulatory environment
  • Ability to manage multiple priorities and deliver results in a fast-paced environment

🎁 Benefits

  • Hybrid working arrangement with flexible hours
  • Opportunity to work from home
  • Typically work from office 2–3 days per week depending on FTE
  • Supportive and collaborative team culture
  • Equal opportunity employer
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