Aixial Group, CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten family. We are...

Aixial Group, CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten family. We are developing our activities in France, Belgium, Germany, Czech Republic, Denmark, UK, US...with even more prospects for expanding internationally.


Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,... activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR...


We are currently looking for a Clinical Project Manager (Cosmetics) M/W


Your main responsibilities at Project Level:


  • Provide relevant information to the Scientific Claim Manager for clinical plan set up
  • Propose optimisation of the clinical plan and the Target Product Profile along with the Project leader
  • Ensure a regular and consistent communication within Scientific Claim Manager and Global Claim Operations Senior Manager
  • Update project milestones, clinical planning tool or organisational tracker (costs, resource, and timing) as per internal processes
  • Report monthly to the Global Claim Operations Senior Manager on ongoing activities, alert when issues raising and propose corrective actions
  • Actively contribute to the validation and preparation of the summary of results and presentation for claim validation at the end of the project
  • Identify variances and present solutions/alternatives by optimising the clinical plan in collaboration with the project planning and Global Claim Operations Senior Manager


Your tasks at operational Level:


  • Accountable for the setup, execution, and follow-up of the clinical program within budget and timelines
  • Operate within the Process defined for the different activities
  • Coordinate the activities and oversight the CROs for the execution of the clinical study Monitoring
  • Work closely with the Medical Expert and Safety Assessor for safety of the clinical studies
  • Responsible to inform the clinical Safety group in case of any Related AE/SAE and/or Pregnancy according process described in Safety SOP
  • Collaborate with Clinical Trial Administrator to ensure appropriate administration of the clinical studies.


Requirements:


  • Experience of clinical research in Dermo-cosmetic or equivalent
  • Strong understanding of cosmetic development process and global environment (regulation, skin investigational technologies)
  • Experience in the management of multiple development projects
  • Extensive experience in clinical trial planning and oversight, interacting with clinical investigators and Contract Research Organizations
  • Experience in working cross-functionally and building collaborative working relationships
  • Entrepreneurial spirit with a “can do” attitude, a commitment to teamwork and an initiative taker
  • Developed autonomy in decision making and knowledge of the working environment


Please send your application to the following e-mail address: [email protected].

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