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Senior Clinical Study Manager

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

Published on Jobat.be 6 days ago

Senior Clinical Study Manager

Job description

The Clinical Study Manager is responsible for the oversight of multiple clinical trials from the protocol concept to the clinical study report, ensuring the quality of the trial and the completion of study deliverables. The main responsibilities include:

  • 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 management, hiring and assessment of appropriate CROs and third party study vendors
  • 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
  • Develop and maintain good working relationships with investigators and study staff
  • 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
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.), provide reports as required to upper management and determine appropriate action in conjunction with study team (autonomy may vary with experience)
  • Oversee the global study budget of a clinical trial
  • Supervise and train CRAs/Clinical Trial Assistants allocated to the studies

Profile

  • Scientific Background (minimum Bachelor’s degree)
  • At least 5 years’ experience as 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 Senior Clinical Study Manager of solliciteer online op de vacature Senior Clinical Study Manager.

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Characteristics

Requirements

  • Academic Bachelor

Offer

  • Permanent
  • Independent
  • Full-time
  • Company car

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