Posizione: Entry level

Tipo di lavoro: Full-time

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Contenuto del lavoro

Establish and maintain key clinical operations databases (enrolment, KPIs, material shipments, site contacts, essential documents, etc.)
  • Setup and maintenance of Trial Master Files and Investigator Office files
  • Manage documentation of clinical studies in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
  • Support organization of Clinical meetings (internal meetings, CRA meetings, investigator meetings, etc.) incl. agenda, minutes and logistics
  • Act as central contact for the clinical operations team for department communication, correspondence, and associated documentation
  • Actively support the CTM and team to :
  • Perform study sites activation
  • Establish & maintain excellent relationship with study sites
  • Ensure study process improvements implementation (i.e. input in SOPs/WI)
  • Prepare all external & internal documentation for assigned trials (as per study protocol, SOP’s, and GCP requirements).
Bachelor or Master’s degree in a (para-) medical or scientific field
  • 5+ years, at least, of experience in a similar role
  • At least two years of working experience within biotech industry or hospital, highly desired
  • GCP training and certification are mandatory.
Creative and finding ways to get the job done
  • Thriving in challenging environments and finds ways to remove obstacles
  • Flexible mindset capable to manage change and deal with ambiguity
  • Proven ability to navigate complex projects
  • Autonomous, pro-active, flexible and assertive personality. Driven to achieving highest results
  • Efficient in planning and executing work: ability to multi-task yet prioritize activities at once
  • Team player, able to navigate into matrix organization in multi-cultural environment
  • Very strong attention to details
  • Ability to organize and classify complex technical documentation
  • Excellent communicator able to structure information and share it within the team and across departments
  • Hands-on attitude.
  • Proficient with Microsoft office suite
  • Fluent in English and French or Dutch knowledge (oral and written), additional languages are an asset.
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Scadenza: 31-12-2025

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