Belgique 27.05.2020

Clinical Project Manager

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.

We are currently looking for an experienced Clinical Trial Manager (located in Walloon Brabant)  to drive all assigned clinical operations’ activities related to the clinical studies from protocol summary, study site selection and regulatory activation process to Clinical Study Report:

  •  Select and activate chosen study sites, establish and maintain an excellent relationship with site investigators and research teams;
  • Create and update activities in overall project plan on a regular basis to assure appropriate outcome of clinical trial projects in terms of scope, timelines and objectives;
  • Coordination of assigned CRA monitoring activities;
  • Ensure study quality/GCP compliance to deliver a rigorous patient data;
  • Partner with Clin Ops Director and provide oversight to all vendors or study delivery team, ensuring timely delivery of milestones and budget compliancy;
  • Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs;
  • Liaise with manufacturing, central lab, and other study project stakeholders as needed;
  • Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans);
  • Works with the Clin Ops Team to develop and maintain study timelines;
  • Responsible for ensuring vendors deliver according to scope of work and review/approve vendor invoices.

Requirements

  • Master Degree (in  Life Science domain)
  • Ideally fluent in ENG/FRE/DUT
  • Minimum of 3 years’ experience in clinical project managemen
  • Minimum of 5 years’ previous experience as CRA (at CRO or at sponzor)
  • Experience in early stage oncology trials (experience in Biotech is a plus)
  • Flexibility and ability to adapt and learn quickly
  • Ability to work under pressure and to tight deadlines
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