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Country Study and Study Start-up Specialist

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

Published on Jobat.be 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

Profile

  • 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

Offer

  • 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

Interested?

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Country Study and Study Start-up Specialist of solliciteer online op de vacature Country Study and Study Start-up Specialist.

Brussels

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33 days left to apply

Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time
  • Company car

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