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Clinical Project Manager - Belgium  

Company managed [?] Still accepting applications
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Posted on : 01 December 2016

Project Description

We are looking for a Clinical Project Manager 

Overall Mission: 

The Clinical Project Manager (CPM) is responsible for the setup, the execution of a clinical trial and the generation of clinical data supporting registration of the IMP on a defined Market. This will be done as per the defined timelines and the budget. 

Job description 

  • Define study  timelines,  sets  milestones  and  track  study  progress  against  endorsed plans, 
  • Contribute  to  Study  operational  feasibility  (interaction  with  CROs,  Key  opinion leaders,), 
  • Responsible  for  coordinating the  preparation  of  the  clinical  dossier in support  to the Medical  Director and  the  Study  manager (writing  of  the study documents,  contracts negotiation, define the key documents for submission.), 
  • Accountable for the preparation of study documents (CRF, monitoring guidelines, safety guidelines, any study specific procedures), 
  • Coordinates the input/deliverable of the different contributing teams (monitoring CRO, pre-clinic, production and medial Affairs), 
  • Ensure all the country specific requirement are shared with the study team, followed-up on and timely met (safety or regulatory matters), 
  • Perform in-process control all along the study setup up to reports are disclosed, 
  • Ensures that study is conducted in compliance with study protocol, with ICH- GCP and that safety, right and well-being of patients are preserved, 
  • Maintain  study  timelines  and  budget  within  the  agreed  plan  by  monitoring  progress (interaction with SM and Monitors and use of ms  project, budget plan) and in case of deviation, putting suitable contingency plan, 
  • Responsible  for  ensuring  Data  are produced  and  collected  with  quality  by  using management tools (risk management, protocol deviation management,), 
  • Participates  to  the  blind  review  meeting,  reviews  the  study  results  provided  by statistical team, reviews and inputs on the CSR draft version to final, 
  • Ensure  that  the  services  agreed  between  the  company  and  the  service  provider  are delivered accordingly, Active  contribution  as  per  needs  in Scientific  advices,  Advisory  boards,  scientific meeting, Support the Regulatory Manager and the Safety manager in tasks such as DSUR / PIP / RMP / SmPC /MAA Dossier by Providing material for the writing to the MW (+ review) and Coordinate filing).

Education and Skills 

  • Master or PhD in life sciences or equivalent scientific background, 
  • Minimum of 5 year experience in clinical research,  
  • Fluency in English (written and oral), 
  • Analytic and synthetic capacity,   
  • Adaptability to fast changing environment & Solution oriented, 
  • Effective presentation skills, 
  • Ability to manage competing priorities, 
  • Strong software and computer skills, including MS Office applications, 
  • Ability  to  establish  and  maintain  effective  working  relationships  with coworkers, managers and clients, 
  • In  depth  knowledge  of,  and  skill  in  applying,  applicable  clinical  research  regulatory requirements;  i.e.,  Good  Clinical  Practice  (GCP)  and  International  Conference  on Harmonisation (ICH) guidelines, 
  • Strong  communication  and  interpersonal  skills,  including  good  command  of  English language, 
  • Strong organizational and problem solving skills, 
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics. 

About Us

We are  a  Belgian  clinical  stage  biopharmaceutical  company  focused  on  the development  and future  commercialisation  of  a  range  of  breakthrough  immunotherapy products for the treatment of allergies. We have a headcount of 22 staff members, located at our headquarters and in the laboratory.