Job Description

Senior CRA/ Clinical Trial Manager (CTM)

Belgium Pharmaceuticals Employee
Posted by Katleen Broeckhoven on 07/07/2020

Are you experienced in managing Clinical Trials? More specifically in Phase I and beyond? We are looking for a Senior CRA/ Clinical Trial Manager (CTM) for a major global R&D company. Interested? Please make yourself known on www.novellashealthcare.com!

Job Description:

The CRM provides guidance and leadership to representatives of various internal and vendor functions involved in the initiation, conduct/execution and/or finalization of Early Development (ED) and Phase IIa studies. The CRM is responsible for the operational management of one or more clinical trials, and he/she may be assigned to one or more of the below listed responsibilities:

  • Give study-design related input/feedback, in collaboration with Disease Area Scientist(s) and other internal partners
  • Reports trial status, progression and operational issues to the Clinical Team, as appropriate
  • Responsible for the operational implementation of disease specific and patient segmentation assay systems
  • Serve as the primary point of contact for Service Providers (vendors)
  • Participates in the identification and selection of clinical sites and Service Providers
  • Leads Site feasibility and vendor selection
  • Participates in or leads Clinical Working Group (study team) Meetings including those with the vendors
  • Is in close contact with the Global Clinical Organisation
  • Assures timely submission to Competent Authorities (i.e. HA and EC/IRB), before, during and after conduct of the study, in collaboration with experts of relevant functional areas
  • Oversees interactions / organizes coordination meetings with external vendors involved in the study; coordinates and chairs the meetings as needed.
  • Assures escalation and documentation of issues (site issues, central issues etc.)
  • Assures study timelines are met, as agreed upon with the CDT
  • Develops, tracks and keeps oversight on study budget and keeps study budget within pre-agreed limits
  • Assures overall quality of the study and adherence to study protocol, GCP and applicable SOPs
  • Performs co-monitoring visits when desired/required
  • Contributes to generation and review of the protocol synopsis and the full protocol.
  • Contributes to and reviews Clinical Study Report
  • Assist in SOP development, if required

 

Job Requirements:

  • Minimum Master’s degree– such as pharmacy, biology, biotechnology, etc
  • Experience in early clinical development, with emphasis on Clinical Study Management, supported by previously gained experience in clinical study monitoring
  • Fluent in written and spoken English
  • Reside in Belgium
  • Knowledge of Good Clinical Practice and ICH Guidelines is a must
  • Knowledge and Early Development, Phase I and Phase II environment is a must
  • Knowledge of Immunology (scientific knowledge) is an asset
  • Teamwork experience
  • Experience of working in a matrix-structured organization is an asset
  • Good Project Management Skills
  • Solid scientific reasoning skills
  • Excellent Communication Skills
  • Good presentation skills
  • Good knowledge about Microsoft Office applications (Word, Excel, Power Point, Outlook)
  • Ability to manage several studies simultaneously and to identify priorities
  • Ability to advise, persuade and negotiate with colleagues in a supportive and constructive fashion
  • Excellent decision-making skills

 

 

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