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Country Study and Study Start-up Specialist

Pauwels Consulting | Anderlecht | Permanent, Independent, Full-time

Published on 6 days ago

Country Study and Study Start-up Specialist

Job description

  • Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures
  • Executes all start-up activities prior to site activation on assigned studies
  • Prepares country level Informed Consent Form (ICF) and obtains ethics committees' and local regulatory authorities' approval
  • Maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
  • Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions
  • In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required
  • Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment
    Plans and Study Newsletters
  • Supports/coordinates the negotiation of site budgets,
    budget plans and provides oversight for site payments per contract
  • Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of nonproductive sites and tracking of safety procedures
  • Supports management of country-level Trial Master File (TMF) and reviews for quality (including
    translations, as applicable)
  • Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance


  • University degree or equivalent in a medical/science-related field 
  • Experience demonstrating knowledge and understanding of clinical trials
  • Monitoring experience is desirable
  • Demonstrated knowledge and understanding of ICH-GCP, as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials
  • Trilingual: FR-DU-EN


  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees


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33 days left to apply



  • Master (University or Higher Education Long Type)


  • Permanent
  • Independent
  • Full-time
  • Company car

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