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Junior Clinical Study Manager

Pauwels Consulting | Mont-Saint-Guibert | Permanent, Independent, Full-time

Published on Jobat.be 11 days ago

Junior Clinical Study Manager

Job description

The Clinical Study Manager is responsible for coordinating all operational aspects of a clinical trial. The main responsibilities are the following:

  • Collaborate with Medical and Clinical Affairs department and with all other departments in the overall study management of a clinical trial
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Assist in identification, budget negotiation, hiring and follow-up of appropriate CROs and third party study vendors
  • Assist with CRA and third party vendor training on protocols and practices
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Identify, select, and monitor performance of investigational sites for clinical studies
  • Prepare accurate and timely visit reports from all site interaction visits
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
  • Plan, organize and lead internal and external meetings and conference calls
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits
  • Oversee the global study budget of a clinical trial
  • Perform clinical data review of data listings and summary tables, including query generation

Profile

  • Scientific Background (minimum Bachelor’s degree)
  • Previous experience as CRA, Lead CRA or Clinical Study Manager.
  • ICH-GCP training
  • Good skills in Microsoft Office (Word, Excel, Power Point, Outlook) and experience in EDC systems.
  • Fluency in English

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 Junior Clinical Study Manager of solliciteer online op de vacature Junior Clinical Study Manager.

Wavre

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28 days left to apply

Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time
  • Company car

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